CDER SBIA Learn

Global IDMP Implementation – Getting Closer to the Goal Webinar 10/16/2024 Data Standards, Drug Shortages, Labeling, Electronic Submissions, Pharmacovigilance, Regulatory Submissions No ICH M12 Drug-Drug Interaction Studies Final Guidance Webinar 10/9/2024 Drug Interaction, New Drug Development, IND No Advancing Generic Drug Development: Translating Science to Approval 2024 Conference/Workshop 9/24/2024 ANDA, Complex Generic Drug, Product Specific Guidances, Generic Drug Development, Regulatory Assessment No Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2024 Conference/Workshop 9/12/2024 Import/Export, International, Registration and Listing No FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA Webinar 9/4/2024 Biologics, Chemistry, Manufacturing, and Controls (CMC), Clinical Trials and Research, Early Product Development, Devices, Digital Health Technologies, Drug Development No Environmental Monitoring in Compounding Webinar 7/30/2024 Compounding, Environmental Monitoring, Outsourcing Facilities No Dataset-JSON Pilot Report and Next Steps Webinar 7/25/2024 Data Standards, International, Regulatory Science, Regulatory Submissions No Introduction to FDA’s Office of Trade and Global Partnerships Webinar 7/23/2024 Combination Products, Drug Supply, International Trade No Office of Pharmaceutical Quality (OPQ) Reorganization On Demand 7/16/2024 Drug Quality, Emerging Technology, International, Manufacturing, Quality Assessments, Supply Chain No Rx Drug Promotion and the Clear, Conspicuous, and Neutral Final Rule Webinar 6/26/2024 Advertising, Marketing, Regulatory Submissions No OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration Webinar 6/18/2024 OTC Regulation, User Fees No OSIS Workshop: CDER Inspections of Good Laboratory Practice and Bioavailability/Bioequivalence Study Sites Webinar 6/13/2024 Animal Rule, Bioanalysis, Bioavailability, Bioequivalence, Clinical Trials and Research, Good Laboratory Practice No Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development Conference/Workshop 5/29/2024 Advanced Manufacturing, Artificial Intelligence, Biologics, Clinical Trials and Research, Combination Products, Devices, Drug Safety, Drug Supply Chain, Electronic Submissions, New Drug Development No Considerations for Drug Products that Contain Nanomaterials SBIA Chronicles Podcast 5/17/2024 Nanomaterials No Considerations for Drug Products that Contain Nanomaterials SBIA Chronicles  5/17/2024 Nanomaterials No Statistical Considerations for Premarketing Risk Assessment Webinar 5/16/2024 Clinical Trials and Research, New Drug Development, Integrated Safety Analyses No Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval Webinar 5/9/2024 ANDA, Generic Drug Development, Meetings, Regulatory Assessments No Facilitating Generic Drug Product Development through Product-Specific Guidances Webinar 4/25/2024 ANDA, Bioequivalence, Generic Drug Development, Product Specific Guidances No Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access Conference/Workshop 4/10/2024 ANDA, Bioequivalence, Chemistry Manufacturing and Controls (CMC), Controlled Correspondence, Generic Drug Development, Meetings, Product Specific Guidances No Expanding Generic Drug Access Through International Engagements Webinar 2/28/2024 ANDA, Bioequivalence, Clinical Trials and Research, Complex Generic Drug, Generic Drug Development, International No Integrated Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes Webinar 3/7/2024 Clinical Trials and Research, New Drug Development, Integrated Safety Analyses No Joint US FDA – Health Canada ICH Public Meeting Webinar 2/22/2024 International, New Drug Development, Generic Drug Development, Safety, Real Word Evidence, Analytical Validation, Drug Safety, Data Management No A Deep Dive: FDA’s Model-Integrated Evidence (MIE) Industry Meeting Pilot Program for Generic Drugs Webinar 1/18/2024 Generic Drug Development, Bioequivalence, ANDA, Meetings No eCTD (7/28) Generic Drugs Forum 201 Webinar 4/4/2017 ANDA, Generic Drug Development, Regulatory Submissions Disponible/Available Introduction to “The ANDA Review Pathway” (11/28) Generic Drugs Forum 2017 Webinar 4/4/2017 ANDA, Generic Drug Development, Regulatory Submissions Disponible/Available FDA’s Bioequivalence Recommendations for Generic Drugs (16/28) Generic Drugs Forum 2017 Webinar 4/4/2017 ANDA, Bioequivalence, Generic Drug Development, Regulatory Assessment Disponible/Available Manufacturing Process and Controls (25/28) Generic Drugs Forum 2017 Webinar 4/4/2017 ANDA, Chemistry Manufacturing and Contgrols (CMC), Drug Quality, Generic Drug Development Disponible/Available Drug Master Files (DMFs) from an ANDA Perspective (7of28) Generic Drugs Forum – Apr. 3-4, 2019 Webinar 4/3/2019 ANDA, Drug Master Files, Generic Drug Development, Regulatory Assessment, Regulatory Submissions  Disponible/Available Orange Book – Its Role in ANDAs (8of28) Generic Drugs Forum – Apr. 3-4, 2019 Webinar 4/3/2019 ANDA;Generic Drug Development; New Drug Development; Orange Book Disponible/Available Product Specific Guidances (PSGs) Generic Drugs Forum 2020 Webinar 4/15/2020 ANDA; Complex Generic Drug; Generic Drug Development; Product Specific Guidances Disponible/Available Post-approval Considerations for Changes to Manufacturing Process and Facilities – REdI 2020 Webinar 6/30/2020 Manufacturing; Regulatory Submissions Disponible/Available FDA Drug Manufacturing Inspections – REdI 2020 Webinar 6/30/2020 Manufacturing; Inspections; Regulatory Submissions Disponible/Available ANDA Postapproval Changes: Best Practices and Strategies to Avoid Common Quality Assessment Issues Webinar 4/28/2021 ANDA; Generic Drug Development; Quality Assessments Disponible/Available A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium Symposium 2/13/2024 New Drug Development, Clinical Trials and Research, ANDA, Bioequivalence, BLA, Digital Health Technologies, International, Regulatory Assessment, Inspections No Navigating Complex Waters: A Deep Dive into FDA Drug Interactions Guidances and Resources Webinar 12/12/2023 IND, Labeling, Drug Interaction, Therapeutic Protein No FDA Clinical Investigator Training Course (CITC) 2023 Conference/Workshop 12/6/2023 IND, Clinical Trials and Research, New Drug Development, Real World Evidence, International, Digital Health Technologies No Toward Global IDMP Implementation: A Focus on Global Use Cases Webinar 11/28/2023 Regulatory Submissions, Data Standards No Common Issues with SEND Data Submitted for Safety Pharmacology Studies Webinar 11/16/2023 Regulatory Submissions, Data Standards No Implementing DSCSA: Stabilization Period and Expectations Webinar 11/3/2023 DCSA, Compliance, Drug Supply Chain, Wholesaler, Distributor, Unique Serial Numbers No Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing Symposium 10/31/2023 Drug Quality, Quality Assessments, Supply Chain, Manufacturing, Emerging Technology No BsUFA III Regulatory Science Pilot Program Webinar 10/16/2023 Biomarkers, Regulatory Science, BLA, Biologics No 2023 NanoDay Symposium: Continuous Manufacturing of Nanomaterials Symposium 10/11/2023 Generic Drug Development, New Drug Development, IND, NDA, BLA, ANDA, Nanomaterials, Non-Clinical, Quality Assessment, Continuous Manufacturing, Regulatory Science, Delivery System, Lipid, Liposome No Electronic Drug Registration and Listing (eDRLS) Using CDER Direct – 2023 Conference/Workshop 9/28/2023 Registration and Listing, Import/Export No Use of Biomarkers for Diagnosing and Assessing Treatment Response in Noncirrhotic NASH Trials Conference/Workshop 9/18/2023 Clinical Trials and Research, New Drug Development, Biomarkers, Surrogate Endpoints, Noninvasive tests, Noncirrhotic NASH No Advancing Generic Drug Development: Translating Science to Approval 2023 Conference/Workshop 9/13/2023 ANDA, Generic Drug Development, Complex Generic Drug, Product Specific Guidances, Regulatory Assessment No Understanding FDA Inspections and Data Webinar 9/6/2023 Inspections, International, Current Good Manufacturing Practice (CGMP) No OTC Monograph Reform: OMOR Format and Content & Electronic Submissions Webinar 8/22/2023 OTC Drug Regulation, Regulatory Submissions, ANDA, NDA, New Drug Development No Using Bayesian Statistical Approaches to Advance our Ability to Evaluate Drug Products  SBIA Chronicles Podcast 8/17/2023 Clinical Trials and Research No Using Bayesian Statistical Approaches to Advance our Ability to Evaluate Drug Products SBIA Chronicles 8/17/2023 Clinical Trials and Research No ClinicalTrials.gov – a Three-Part Series Webinar 8/9/2023 ClinicalTrials.gov, Clinical Trials and Research No Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products SBIA Chronicles 7/11/2023 Generic Drug Development No Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products SBIA Chronicles Podcast 7/11/2023 Generic Drug Development No Decentralized Clinical Trials (DCT) Draft Guidance Webinar 6/20/2023 Clinical Trials and Research, IND, New Drug Development No

Overview: Clinical Pharmacology Considerations for Food Effect Studies

Webinar 6/15/2023 Drug Development, Regulatory Submissions No

Regulatory Education for Industry (REdI) Annual Conference 2023

Conference/Workshop 6/5/2023 BLA, Chemistry Manufacturing and Controls (CMC), Digital Health Technologies, Drug Development, FDA Meetings/Communications, IND, NDA, New Drug Development, Real World Evidence, and Regulatory Submissions No

An Update on Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR)

Webinar 5/24/2023 Drug Quality, Regulatory Submissions, and Quality Assessments No

OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2023 User Fees and Registration

Webinar 5/16/2023 OTC Drug Regulation, User Fees No

A Deep Dive: GDUFA III Scientific Meetings

Webinar 5/15/2023 ANDA, Generic Drug Development, FDA Meetings/Communications No

Navigating the First ICH Generic Drug Draft Guideline “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”

Webinar 5/2/2023 Generic Drug Development, International No

Electronic Systems, Electronic Records, and Electronic Signatures Webinar

Webinar 4/25/2023 New Drug Development, Clinical Trials and Research, IND No

FDA’s Dosage and Administration Section of Labeling Draft Guidance

Webinar 4/19/2023 Labeling No

The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development

SBIA Chronicles Podcast 4/10/2023 Biosimilars No

The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development

SBIA Chronicles 4/10/2023 Biosimilars No

Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF

Conference/Workshop 4/7/2023 Generic Drug Development No

A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence

Webinar 3/14/2023 Bioequivalence, Generic Drug Development, Drug Development No

Joint US FDA – Health Canada ICH Public Meeting

Webinar 2/24/2023 Clinical Trials and Research, International, New Drug Development No

Overview: Clinical Pharmacology Considerations for Neonatal Studies

Webinar 2/15/2023 Clinical Trials and Research, IND, NDA, BLA, New Drug Development No

FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds

SBIA Chronicles 2/6/2023 Drug Quality No

FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds

SBIA Chronicles Podcast 2/6/2023 Drug Quality No

Overview of FDA’s Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use

Webinar 2/1/2023 OTC Drug Regulation No

FDA’s Labeling Resources for Human Prescription Drugs

Webinar 1/26/2023 Labeling No

Reporting Individual Case Study Reports (ICSRs) to FAERS Using ICH E2B R3 Standards

Webinar 1/13/2023 Regulatory Submissions, Safety No

What to Expect after an Inspection: 483s, Responses and Beyond

Webinar 12/14/2022 Compliance, Compounding, Inspections, FDA Form 483 No

FDA Clinical Investigator Training Course (CITC) 2022

Conference/Workshop 12/7/2022 IND, Clinical Trials and Research, New Drug Development, Real World Evidence, International, Digital Health Technologies No

Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions

Conference/Workshop 11/30/2022 ANDA, Drug Master Files, Generic Drug Development, Regulatory Submissions, Quality Assessments No Proposed Rule: Revising the National Drug Code Format and Drug Label Barcode Requirements Webinar 11/17/2022 Registration and Listing No

An In-Depth Look at the Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs – General Considerations

Webinar 10/26/2022 Drug Development, New Drug Development, Bioequivalence, Bioavailability, IND, NDA No FDA NanoDay Symposium 2022 Symposium 10/11/2022 Generic Drug Development, New Drug Development, IND, NDA, Chemistry Manufacturing and Controls (CMC), Nanomaterials, Non-Clinical, ANDA No Study Data Standards Update for CBER: Your Guide to a Successful Submission Webinar 10/6/2022 Data Standards, Regulatory Submissions No

The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities

SBIA Chronicles 9/29/2022 Compounding No

The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities

SBIA Chronicles Podcast 9/29/2022 Compounding No Advancing Generic Drug Development: Translating Science to Approval Conference/Workshop 9/20/2022 Generic Drug Development, Drug Quality, Regulatory Submissions No Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act Webinar 9/8/2022 Registration and Listing No Regulatory Best Practices for Global Access to Medicines, Including Anti-TB Medicines Conference/Workshop 8/16/2022 Drug Development, Drug Quality, Generic Drug Development, New Drug Development, IND, International, Post Approval No Best Practices for Topical Generic Product Development and ANDA Submission Webinar 8/11/2022 Generic Drug Development No Decoding the Guidance: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use Webinar 8/10/2022 Generic Drug Development No Office of Study Integrity and Surveillance (OSIS) Workshop 2022: CDER Inspections of Good Laboratory Practice, Animal Rule, and Bioavailability/Bioequivalence Study Sites Conference/Workshop 7/19/2022 Drug Development, Inspections, New Drug Development, IND No

An FDA Self-Audit of Continuous Manufacturing for Drug Products

SBIA Chronicles 6/28/2022 Drug Quality No

An FDA Self-Audit of Continuous Manufacturing for Drug Products

SBIA Chronicles Podcast 6/28/2022 Drug Quality No Regulatory Education for Industry (REdI) Annual Conference 2022 Conference/Workshop 6/6/2022 Biosimilars, Drug Development, DSCSA, FDA Meetings/Communications, Inspections, NDA, New Drug Development, Regulatory Submissions, Resources, Safety No Quality Management Maturity Workshop Webinar 5/24/2022 Drug Quality No US-Canada Regional ICH Consultation Webinar 5/11/2022 Clinical Trials and Research; International; New Drug Development No FDA Workshop on the Role of Phytosterols in PNALD/IFALD Webinar 5/6/2022 Drug Development No Generic Drugs Forum 2022: The Current State of Generic Drugs Conference/Workshop 4/26/2022 Generic Drug Development No The Key Elements of Being “Recall-Ready” CDER SBIA Chronicles 4/20/2022 Recalls No The Key Elements of Being “Recall-Ready” CDER SBIA Chronicles Podcast 4/20/2022 Recalls No Proposed Rule: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers Webinar 4/13/2022 DSCSA No FDA Inspections of Outsourcing Facilities Webinar 4/6/2022 Compounding, Inspections No Immunogenicity Information in Labeling Webinar 4/5/2022 Drug Development, Labeling No OTC Monograph Reform: Overview of Draft Guidance for Formal Meetings Webinar 3/29/2022 OTC Drug Regulation, Clinical Trials and Research, Regulatory Submissions, FDA Meetings/Communications No FDA-EMA Parallel Scientific Advice (PSA) Program Webinar 3/16/2022 New Drug Development, Drug Development, International, Regulatory Submissions No Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA Webinar 2/24/2022 Drug Development, Generic Drug Development No CDER BIMO GCP Compliance and Enforcement Webinar 2/16/2022 Clinical Trials and Research, Inspections, New Drug Development No Digital Health Technologies (DHTs) for Remote Data Acquisition Draft Guidance Webinar 2/10/2022 New Drug Development, Clinical Trials and Research, IND No Toward Global Identification of Medicinal Products (IDMP) Implementation: A Focus on Biologics Webinar 1/27/2022 New Drug Development, Labeling, Post Approval, Clinical Trials and Research No OTC Monograph Reform: Deemed Final Orders Webinar 12/15/2021 OTC Drug Regulation No OTC Monograph Reform: OTC Sunscreen Drugs Webinar 12/15/2021 OTC Drug Regulation No Clinical Investigator Training Course (CITC) Update Webinar 12/7/2021 Clinical Trials and Research, New Drug Development No Pharmaceutical Quality Symposium 2021: Innovations in a Changing World Conference/Workshop 10/26/2021 Drug Quality No Pharmaceutical Quality Symposium 2021 Part 1 with Keynote Addresses Conference/Workshop 10/26/2021 Drug Quality No Pharmaceutical Quality Symposium 2021 Part 2, FDA Leaders Panel Discussion Conference/Workshop 10/26/2021 Drug Quality No Pharmaceutical Quality Symposium 2021 Part 3 Panel Questions and Discussion Conference/Workshop 10/26/2021 Drug Quality No Pharmaceutical Quality Symposium 2021 Part 4 Conference/Workshop 10/26/2021 Drug Quality No Pharmaceutical Quality Symposium 2021 Part 5 Conference/Workshop 10/26/2021 Drug Quality No Pharmaceutical Quality Symposium 2021 Part 6 Conference/Workshop 10/26/2021 Drug Quality No Pharmaceutical Quality Symposium 2021 Part 7 Conference/Workshop 10/26/2021 Drug Quality No Pharmaceutical Quality Symposium 2021 Part 8 Conference/Workshop 10/26/2021 Drug Quality No Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 1 with Keynote Address Conference/Workshop 10/13/2021 Registration and Listing No Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 2 Conference/Workshop 10/13/2021 Registration and Listing No Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 3 Conference/Workshop 10/13/2021 Registration and Listing No Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 4 with Closing Remarks Conference/Workshop 10/13/2021 Registration and Listing No Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Conference/Workshop 10/13/2021 Registration and Listing No Webinar 10/5/2021 DSCSA No Investigator Responsibilities — Safety Reporting for Investigational Drugs and Device Webinar 9/29/2021 IND, Safety No Advancing Generic Drug Development: Translating Science to Approval Conference/Workshop 9/21/2021 Generic Drug Development No Advancing Generic Drug Development: Translating Science to Approval Keynote Address Conference/Workshop 9/15/2021 Generic Drug Development No COVID-19 Impact on Generic Drug Regulation and Evaluation + QA Conference/Workshop 9/15/2021 Generic Drug Development No Considerations in Assessing Generic Drug Products of Oral Dosage Forms + QA Conference/Workshop 9/15/2021 Generic Drug Development No Complex Generics_Complex Injectables, Opthalmic, and Otic Products, Part 1 + QA Conference/Workshop 9/15/2021 Generic Drug Development No Complex Generics_Complex Injectables, Opthalmic, and Otic Products, Part 2 + QA Conference/Workshop 9/15/2021 Generic Drug Development No Advancing Generic Drug Development: Translating Science to Approval, Day One Closing Remarks Conference/Workshop 9/15/2021 Generic Drug Development No Cutting Edge Science in Complex Generics + QA Conference/Workshop 9/15/2021 Generic Drug Development No Complex Generics_Nasal and Inhalation Products + QA Conference/Workshop 9/15/2021 Generic Drug Development No Complex Generics_Topical Products, Part 1 + QA Conference/Workshop 9/15/2021 Generic Drug Development No Complex Generics_Topical Products, Part 2 + QA Conference/Workshop 9/15/2021 Generic Drug Development No Advancing Generic Drug Development: Translating Science to Approval, Day Two Closing Remarks Conference/Workshop 9/15/2021 Generic Drug Development No The ABCs of Product Specific Guidances CDER SBIA Chronicles 9/2/2021 Generic Drug Development No The ABCs of Product Specific Guidances CDER SBIA Chronicles Podcast 9/2/2021 Generic Drug Development No Promotional Submissions in eCTD Format – Grouped Submissions Webinar 8/31/2021 Regulatory Submissions No Manufacturing, Supply Chain, and Inspections during the COVID19 Public Health Emergency Webinar 8/25/2021 Inspections; Drug Quality; DSCSA No

Regulatory Education for Industry (REdI) Annual Conference 2021

Conference/Workshop 7/19/2021 New Drug Development No 2021 REdI Conference Keynote Address by Janet Woodcock, MD Conference/Workshop 7/19/2021 New Drug Development No 2021 REdI Conference Plenary Session with Patrizia Cavazzoni, MD Conference/Workshop 7/19/2021 New Drug Development No OND Reorganization and the New Drugs Regulatory Program Modernization Conference/Workshop 7/19/2021 New Drug Development No ANDA Efforts Related to COVID-19 Conference/Workshop 7/19/2021 Generic Drug Development No Resource Capacity Planning: How CDER is Modernizing Resource Planning Capabilities Conference/Workshop 7/19/2021 New Drug Development No CDER NextGen Portal Conference/Workshop 7/19/2021 Regulatory Submissions No Electronic Common Technical Document (eCTD) Conference/Workshop 7/19/2021 Regulatory Submissions No Product Quality Consideration for Emergency Use Authorizations (EUAs) Conference/Workshop 7/19/2021 New Drug Development No Strategies to Address Potential Medication Errors for EUA Products for COVID-19 Conference/Workshop 7/19/2021 New Drug Development; Safety No Clinical Pharmacology Regulatory Sciences in Drug Development and Precision Medicine Conference/Workshop 7/19/2021 New Drug Development No CDER’s Role in Public Health Emergency Response and Medical Countermeasure Development  Conference/Workshop 7/19/2021 New Drug Development No Where Do We Go from Here? How the Ombudsman Can Help Conference/Workshop 7/19/2021 FDA Meetings/Communications No Communication Best Practices – Interacting with Regulatory Project Managers in CDER/ORO Conference/Workshop 7/19/2021 FDA Meetings/Communications No Communications in a Global Pandemic Conference/Workshop 7/19/2021 FDA Meetings/Communications No Regulatory Policy: Role in Guiding Decision Making in CDER Conference/Workshop 7/19/2021 New Drug Development No Role of the Product Jurisdiction Team in the Medical Product Development Process Conference/Workshop 7/19/2021 New Drug Development No FDA Guidance on Conduct of Clinical Trials of Medical Products During the Public Health Emergency Conference/Workshop 7/19/2021 New Drug Development; Clinical Trials and Research No OSI’s Role in the Drug Development Process and Impact of COVID-19 Conference/Workshop 7/19/2021 New Drug Development No Safety Reporting Requirements and Safety Assessment for IND and BA/BE Studies Webinar 6/29/2021 IND, Safety No Identification of Medicinal Products: Path to Global Implementation Webinar 6/11/2021 International, Labeling, Regulatory Submissions No

OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2021 User Fees Webinar

Webinar 6/3/2021

OTC Drug Regulation

No FDA Study Data Technical Rejection Criteria (TRC): What you need to know! Webinar 5/21/2021 Regulatory Submissions  No FY 2021 Generic Drug Science and Research Initiatives Public Workshop Conference/Workshop 6/23/2021 Generic Drug Development No Welcome, Keynote, and Industry Survey Results – GDUFA Science and Research Initiatives Public Workshop Conference/Workshop 6/23/2021 Generic Drug Development No Generic Industry Challenge Perspectives – GDUFA Science and Research Initiatives Public Workshop Conference/Workshop 6/23/2021 Generic Drug Development No Public Comment – GDUFA Science and Research Initiatives Public Workshop Conference/Workshop 6/23/2021 Generic Drug Development No Panel Discussion with Generic Industry – GDUFA Science and Research Initiatives Public Workshop Conference/Workshop 6/23/2021 Generic Drug Development No Model-Integrated Evidence for Generic Drug Development – Session 1A Conference/Workshop 6/23/2021 Generic Drug Development No Model-Integrated Evidence for Generic Drug Development – Session 1B Conference/Workshop 6/23/2021 Generic Drug Development No Model-Integrated Evidence for Generic Drug Development – Session 1C Conference/Workshop 6/23/2021 Generic Drug Development No Complex Product Characterization/Analysis – Session 2A Conference/Workshop 6/23/2021 Generic Drug Development No Complex Product Characterization/Analysis – Session 2B Conference/Workshop 6/23/2021 Generic Drug Development No Complex Product Characterization/Analysis – Session 2C Conference/Workshop 6/23/2021 Generic Drug Development No In Vitro and In Vivo BE Approaches: Challenges and Opportunities – Session 3A Conference/Workshop 6/23/2021 Generic Drug Development No In Vitro and In Vivo BE Approaches: Challenges and Opportunities – Session 3B Conference/Workshop 6/23/2021 Generic Drug Development No Closing Remarks – Robert Lioberger, PhD, Director, Office of Research and Standards (ORS), OGD, FDA Conference/Workshop 6/23/2021 Generic Drug Development No FDA and Health Canada Regional ICH Consultation Conference/Workshop 5/14/2021 Clinical Trials and Research; International; New Drug Development No FDA and Health Canada Regional ICH Consultation – Part I Conference/Workshop 5/14/2021 Clinical Trials and Research; International; New Drug Development No FDA and Health Canada Regional ICH Consultation – Part II Conference/Workshop 5/14/2021 Clinical Trials and Research; International; New Drug Development No Common Labeling Deficiencies and Tips for Generic Drug Applications Webinar 5/7/2021 Generic Drug Development; Labeling No FDA Product-Specific Guidances: Lighting the Development Pathway for Generic Drugs Webinar 5/5/2021 Generic Drug Development; New Drug Development; Orange Book No Generic Drugs Forum 2021: Lifecycle of a Generic Drug Conference/Workshop 4/28/2021 Generic Drug Development No Generic Drugs Forum 2021: Lifecycle of a Generic Drug: Keynote from Sally Choe, Director, Office of Generic Drugs (OGD) Conference/Workshop 4/28/2021 Generic Drug Development No Office of Pharmaceutical Quality (OPQ) Update Conference/Workshop 4/28/2021 Generic Drug Development; Drug Quality No Global Generic Drug Landscape Conference/Workshop 4/28/2021 Generic Drug Development No Data Integrity Issues in Bioequivalence Studies Conference/Workshop 4/28/2021 Generic Drug Development; Drug Quality No Bioavailability/Bioequivalence Site Evaluation During the Pandemic Conference/Workshop 4/28/2021 Generic Drug Development No Impact of Data Integrity Issues on Pharmacology/Toxicology Studies in ANDAs Conference/Workshop 4/28/2021 Generic Drug Development; Drug Quality No Generic Drugs Forum 2021: Panel Discussion 1 Conference/Workshop 4/28/2021 Generic Drug Development No OPQ Policy Update Conference/Workshop 4/28/2021 Generic Drug Development; Drug Quality No Update on CDER’s Quality Management Maturity Program Conference/Workshop 4/28/2021 Generic Drug Development No Generic Drugs Forum 2021: Panel Discussion 2 Conference/Workshop 4/28/2021 Generic Drug Development No Pre-ANDA Program Conference/Workshop 4/28/2021 Generic Drug Development; FDA Meetings/Communications No Pre-ANDA Program Update and Tips for Success – OPQ Perspective Conference/Workshop 4/28/2021 Generic Drug Development; Drug Quality No Controlled Correspondence Related to Pharmaceutical Quality Conference/Workshop 4/28/2021 Generic Drug Development; FDA Meetings/Communications No Generic Drugs Forum 2021: Panel Discussion 3 Conference/Workshop 4/28/2021 Generic Drug Development No Division of Filing Review: Helpful Tips for Submission of an ANDA or Controlled Correspondence Conference/Workshop 4/28/2021 Generic Drug Development No >ANDA Labeling: Recommendations and Helpful Resources Conference/Workshop 4/28/2021 Generic Drug Development; Labeling No Generic Drugs Forum 2021: Panel Discussion 4 Conference/Workshop 4/28/2021 Generic Drug Development No Addressing Common Challenges in BE Studies Due to COVID-19: OGD’s Approach Conference/Workshop 4/28/2021 Generic Drug Development No Insights from Records Requests under §704(a)(4) of the FD&C Act in lieu of Pre-Approval Inspections Conference/Workshop 4/28/2021 Generic Drug Development No Generic Drugs Forum 2021: Panel Discussion 5 Conference/Workshop 4/28/2021 Generic Drug Development No Mid-Review Cycle Meeting Overview Conference/Workshop 4/28/2021 Generic Drug Development; FDA Meetings/Communications No Information to Include with Cover Letters Conference/Workshop 4/28/2021 Generic Drug Development; FDA Meetings/Communications No Application Communications – Quality Assessment Perspective Conference/Workshop 4/28/2021 Generic Drug Development; Drug Quality No Generic Drugs Forum 2021: Panel Discussion 6 Conference/Workshop 4/28/2021 Generic Drug Development No Fostering Innovation Through OPQ’s Emerging Technology Program Conference/Workshop 4/28/2021 Generic Drug Development No Lab Science to Support Generic Complex Drug Product Assessment Conference/Workshop 4/28/2021 Generic Drug Development No Assessment of Extractables/Leachables Data in ANDA Submissions Conference/Workshop 4/28/2021 Generic Drug Development; Drug Quality No Generic Drugs Forum 2021: Panel Discussion 7 Conference/Workshop 4/28/2021 Generic Drug Development No Biopharmaceutics Risk Assessment to Guide Dissolution Method Development for Solid Oral Dosage Forms Conference/Workshop 4/28/2021 Generic Drug Development; Drug Quality No Integrated Manufacturing Assessment: Expectations Conference/Workshop 4/28/2021 Generic Drug Development; Drug Quality No Building a Better Sterility Assurance Application Conference/Workshop 4/28/2021 Generic Drug Development; Drug Quality No Generic Drugs Forum 2021: Panel Discussion 8 Conference/Workshop 4/28/2021 Generic Drug Development No Postmarketing Safety and Surveillance of Generic Drugs Update Conference/Workshop 4/28/2021 Generic Drug Development No Premarket Review of Expedited Serious Adverse Event Reports of BA/BE Studies Conference/Workshop 4/28/2021 Generic Drug Development; Safety No Update on Shared System REMS for Generic Drug Conference/Workshop 4/28/2021 Generic Drug Development; Safety No ANDA Postapproval Changes: Best Practices and Strategies to Avoid Common Quality Assessment Issues Conference/Workshop 4/28/2021 Generic Drug Development No Generic Drugs Forum 2021: Panel Discussion 9 Conference/Workshop 4/28/2021 Generic Drug Development No Drug Master File (DMF) and Drug Substance Question and Answer Webinar Following March 3-4, 2021 Workshop Webinar 4/9/2021 Drug Master Files No FDA Safety Report Type Flag Requirement for FAERS Submissions Webinar 2/19/2021 Regulatory Submissions; Safety No Oncology Therapy Development Workshop: Pivotal Steps and Avoiding Pitfalls for Start-ups Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research No Oncology Center of Excellence Introduction and Overview of the Oncology Therapy Development Workshop Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research No Innovation Mindset – Advancing Science to Therapies Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research No FDA Oncology Drug Development Overview – Past to Present Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research No Federal Resources for Innovative Cancer Startups: More Than Just Funding Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research No Best Practices for Venture Capital Fundraising: Learn How Early-stage VCs Think Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research No Funding Sources Panel Discussion Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research No Building Your Network and Value to Obtain External Input Prior to Interacting with FDA Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research No Assembling the Best Team to Navigate through Preclinical Development Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research No Consulting Companies and FDA Limitations Panel Discussion Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research No CMC Considerations for CAR T Cell Product Development Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research No CMC Considerations for Oncolytic Viral Product Development Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research No Preclinical Considerations for Cell and Gene Therapy Products, an FDA Perspective Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research No FDA’s Clinical Regulatory Perspective: Designing First-In-Human Trial for Cellular and Gene Therapy Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research No Oncology Therapy Development Workshop Overview, Day Two Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research No Chemistry and Manufacturing Requirements for Early Clinical Development: What’s in there? Prove it. Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research No CMC Considerations for Biotechnology Product Development: A Regulatory Perspective Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research No Getting to First-in-Human for Small Molecules and Biologics Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research No Designing First-In-Human Trials for Small Molecules and Biologics Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research No Planning for Co-development of Companion Diagnostics Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research No Clinical Development of Radiopharmaceuticals a Theranostic Pairs and Dosimetry Considerations Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research No Getting the Best Dose: The Clinical Pharmacology Studies that Help Achieve this Goal Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research No Oncology Center of Excellence Introduction and Overview of the Oncology Therapy Development Workshop: Panel Discussion Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research No Drug Master File (DMF) and Drug Substance Workshop Webinar 3/3/2021 Drug Master Files No Regulatory Perspectives for Development of Drugs for Treatment of NASH Webinar 1/29/2021 New Drug Development; Clinical Trials and Research No OTC Monograph Reform in the CARES Act: Safety Orders Webinar 1/27/2021 OTC Drug Regulation No CDER Compliance Conference Conference/Workshop 1/14/2021 Compliance, Import/Export; Compounding; DSCSA; Safety No Compounding: Cleanrooms and Cleanroom Behaviors: Why they Matter Conference/Workshop 1/14/2021 Compliance, Import/Export; Compounding No Enhanced Drug Distribution Security – Drug Supply Chain Security Act (DSCSA) Implementation Updates Conference/Workshop 1/14/2021 Compliance, DSCSA No A Glance at Drug Importation Requirements Conference/Workshop 1/14/2021 Compliance, Import/Export; Compounding No Risk Evaluation and Mitigation Strategies (REMS) Compliance Program Conference/Workshop 1/14/2021 Compliance, Safety No Drug Master File (DMF) Submissions on New FDA Form 3938 Webinar 1/13/2021 Drug Master File No Diversity in Clinical Trials: Learn about Enrollment Trends and Resources from FDA Webinar 12/16/2020 Clinical Trials and Research No SEND for CBER, What You Need to Know Webninar 12/4/2020 Regulatory Submissions No Guidance for Industry: Referencing Approved Drug Products in ANDA Submissions Webinar 11/20/2020 Generic Drug Development No Office of Prescription Drug Promotion – Core Launch Review Process Webinar 11/20/2020 Marketing No Bridging the Gap – Promoting Safe and Effective Prescription Drug Use in Geriatric Patients Webinar 11/13/2020 Labeling No Office of New Drug (OND) Research: Seeking Collaborators, Funding Opportunities Available  Webinar 11/6/2020 New Drug Development No Celebrating 40 Years: An In-Depth Examination of the FDA Orange Book  Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book No Opening Remarks and FDA’s Orange Book: A Historical Review of 40 Years Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book No Orange Book 101: An Overview of FDA’s Orange Book Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book No How to Update Orange Book Information Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book No How to Update Orange Book Information – Panel Discussion Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book No An Overview of FDA’s Patent Listing Process Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book No Changes to Orange Book Patent Information Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book No Orange Book Patent Information – Panel Discussion Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book No The Patent Information Dispute Process Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book No Best Practices for 505(b)(2) and ANDA Applicants Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book No Patent Dispute and Best Practices for 505(b)(2) and ANDA Applicants – Panel Discussion Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book No Orange Book Exclusivity: An Introduction and Overview Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book No Orange Book Exclusivity: Part I – NCE and 3-Year Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book No Orange Book Exclusivity – Panel Discussion Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book No Orange Book Exclusivity: Part II – Pediatric, Orphan, and GAIN Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book No Orange Book Exclusivity: Part III – 180-Day and Competitive Generic Therapy Exclusivities Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book No Orange Book Exclusivity – Panel Discussion Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book No Orange Book: An Overview of Therapeutic Equivalence Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book No Referencing Approved Drug Products in ANDA Submissions Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book No Orange Book: Looking Towards the Future Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book No Closing Remarks Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book No New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment Webinar 10/15/2020 Drug Development; Clinical Trials and Research No Drug Registration and Listing Workshop Conference/Workshop 10/8/2020 Registration and Listing No Drug Registration and Listing Workshop: Labeler Code Request Conference/Workshop 10/8/2020 Registration and Listing No Drug Registration and Listing Workshop: Establishment Registration Conference/Workshop 10/8/2020 Registration and Listing No Drug Registration and Listing Workshop: Drug Listing Conference/Workshop 10/8/2020 Registration and Listing No Drug Registration and Listing Workshop: 503B Compounder Product Reporting Using CDERDirect Conference/Workshop 10/8/2020 Registration and Listing No Drug Registration and Listing Workshop: Establishment Registration and Drug Listing Compliance Program Conference/Workshop 10/8/2020 Registration and Listing No Overview of the Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs Webinar 10/2/2020 Drug Quality No Advancing Innovative Science in Generic Drug Development Workshop Conference/Workshop 9/29/2020 Generic Drug Development No Dr. Hahn’s Remarks to “Advancing Innovative Science in Generic Drug Development” Workshop 9/29/2020 Conference/Workshop 9/29/2020 Generic Drug Development No Update on GDUFA Science and Research Conference/Workshop 9/29/2020 Generic Drug Development No March 2020 Transition Under the BPCI Act: Impact on Generics Conference/Workshop 9/29/2020 Generic Drug Development No Related Impurities Assessment Considerations for APIs in the Generic Complex Peptide Products Conference/Workshop 9/29/2020 Generic Drug Development No Non-clinical Evaluation of Immunogenicity Risk of Generic Complex Peptide Products Conference/Workshop 9/29/2020 Generic Drug Development No Panel Discussion on Method Development / Validations for Non-traditional Analytical Methods Conference/Workshop 9/29/2020 Generic Drug Development No Developing and Validating Advanced Microscopy Methods for Supporting Complex Product Equivalence Conference/Workshop 9/29/2020 Generic Drug Development No Developing & Validating Commonly Employed Particle Sizing Methods to Support BE and Product Quality  Conference/Workshop 9/29/2020 Generic Drug Development No Quantitative Methods for Determining Equivalence of Particle Size Distributions Conference/Workshop 9/29/2020 Generic Drug Development No Panel for Advanced Analytical and Statistical Methods for Assessing Particle Size Distributions Conference/Workshop 9/29/2020 Generic Drug Development No Assessment of Complex Drug Product – Physicochemical Characteristics to Support In Vitro BE Studies Conference/Workshop 9/29/2020 Generic Drug Development No In Vitro Release Testing for Complex Generics: A Bioequivalence Perspective Conference/Workshop 9/29/2020 Generic Drug Development No In Vitro Bioequivalence Studies of Topical Drug Products: Challenges and Promises of IVRT and IVPT Conference/Workshop 9/29/2020 Generic Drug Development No Panel on Development and Validation Considerations for Drug Release and Permeation Testing  Conference/Workshop 9/29/2020 Generic Drug Development No Formulation Assessments: General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness Conference/Workshop 9/29/2020 Generic Drug Development No Calculating Maximum Daily Dose (MDD) for Orally Administered Drug Products Conference/Workshop 9/29/2020 Generic Drug Development No What’s New in the Inactive Ingredient Database (IID)? Conference/Workshop 9/29/2020 Generic Drug Development No Local Toxicity Considerations for Qualifying Excipients in Generic Drugs Conference/Workshop 9/29/2020 Generic Drug Development No Panel on Excipient and Formulation Considerations  Conference/Workshop 9/29/2020 Generic Drug Development No In Vitro Studies for Alternative BE Approaches to Comparative Clinical Endpoint BE Studies Conference/Workshop 9/29/2020 Generic Drug Development No The Potential of PK BE Studies in Detecting Regional Deposition with Orally Inhaled Drugs Conference/Workshop 9/29/2020 Generic Drug Development No Regional Deposition and Systemic Pharmacokinetic Data of OINDPs with Modeling and Simulation Conference/Workshop 9/29/2020 Generic Drug Development No Panel on Future Directions, Emerging Technology, and Current Thinking on Alternative BE Approaches  Conference/Workshop 9/29/2020 Generic Drug Development No Topical Dosage Forms: Emerging Insights and Implications for Bioequivalence Approaches Conference/Workshop 9/29/2020 Generic Drug Development No In Vivo Dermal Microperfusion & Microdialysis Bioequivalence Approaches Conference/Workshop 9/29/2020 Generic Drug Development No Non-Invasive Raman Spectroscopy-Based Bioequivalence Approaches Conference/Workshop 9/29/2020 Generic Drug Development No Panel on Topical Dermatologic Products  Conference/Workshop 9/29/2020 Generic Drug Development No PBPK to Guide Study Design and Product Development for Generic Dermatological Products Conference/Workshop 9/29/2020 Generic Drug Development No Model-Informed and Model-Integrated Approach in BE Assessment of Long-Acting Injectable Products Conference/Workshop 9/29/2020 Generic Drug Development No Panel on Emerging Use of Modeling and Simulation for Bioequivalence  Conference/Workshop 9/29/2020 Generic Drug Development No Biopharmaceutics Classification System Class 3 Waiver Conference/Workshop 9/29/2020 Generic Drug Development No Using PBPK Absorption Modeling to Support Biopharmaceutics Classification System Class 3 Drug Waiver Conference/Workshop 9/29/2020 Generic Drug Development No Alternatives to f2 Testing for Dissolution Similarity – f2 Bootstrapping and MSD Method Conference/Workshop 9/29/2020 Generic Drug Development No Panel on Practical Considerations in the Study Design and Data Evaluation Recommended in PSGs Conference/Workshop 9/29/2020 Generic Drug Development No A Closer Look into the Nasogastric and Gastric Feeding Tube Study Recommendations Conference/Workshop 9/29/2020 Generic Drug Development No In Vitro Enteral (Nasogastric and Gastric) Feeding Tube Testing of Generic Drugs: Case Studies Conference/Workshop 9/29/2020 Generic Drug Development No Practical Considerations for Bioequivalence of GI Locally-Acting Products Conference/Workshop 9/29/2020 Generic Drug Development No Panel on In Vitro Feeding Tube Testing and GI Locally-Acting Products Conference/Workshop 9/29/2020 Generic Drug Development No Cannabis Clinical Research: Drug Master Files (DMFs) & Quality Considerations Webinar 9/16/2020 Drug Master Files No Real-world Evidence for Drugs, Biologics, and Devices – REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; Real World Evidence; Postapproval No Restructure of the Office of New Drugs (OND) – REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval No So, Your NDA Was Approved – Now What?! Post-approval Responsibilities and Obligations- REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval No Overview of Postmarketing Drug Safety Reporting Requirements – REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval; Safety No Drug Shortages – REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval; Drug Shortages No Enhanced Drug Distribution Security – DSCSA Implementation Updates – REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval; DSCSA No CDER Export Certificate Program – REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval; Import/Export No SBIA Program Overview – REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval; Resources No Post-Approval Submission of Promotional Materials to the OPDP – REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval; Marketing No Requirement for Electronic Submission of an Application and Study Data – REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval; Regulatory Submissions No Overview of Post-approval Chemistry, Manufacture, and Controls (CMC) Changes to an NDA – REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval; Drug Quality  No Lifecycle Changes to Chemistry, Manufacture, and Controls in NDAs – REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval; Drug Quality  No Post-approval Considerations for Changes to Manufacturing Process and Facilities – REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval; Drug Quality  No Questions and Panel Discussion – Post-approval CMC and Manufacturing – REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval; Drug Quality  No FDA Drug Manufacturing Inspections – REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval; Inspections No Bioanalysis of Endogenous Compounds in PK BE Studies in ANDAs – Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development No Bioanalysis of the Dried Blood Spot (DBS) by Mass Spectrometry for Clinical Studies -Bioanalysis  Conference/Workshop 6/30/2020 Generic Drug Development No Bioanalysis of Unstable Analytes in Pharmacokinetic BE Studies for ANDAs – Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development No Bioanalytical Method Validation: History, Process, and Regulatory Perspectives – Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development No Case Study: Bioanalytical Approaches to Mitigate Issues during a BE Inspection – Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development No Common Deficiencies for Study Sample Reanalysis in PK BE for ANDAs – Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development No Considerations on ex vivo Conversion of Prodrugs during Bioanalysis – Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development No CREST Site Selection Model Overview – Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development No Keynote – Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development No Office of Clinical Pharmacology (OCP): Biosimilars – Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development No Office of Clinical Pharmacology (OCP): Drugs and Biologics – Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development No Office of Clinical Pharmacology (OCP): Panel Discussion – Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development No Office of Generic Drugs Panel Discussion – Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development No Office of Study Integrity and Surveillance Session (OSIS) Panel Discussion – Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development No Overview of Immunogenicity Inspections – Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development No Panel Discussion – Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development No Regulated Bioanalysis for Small Molecules – Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development No Regulated Bioanalysis of Large Molecules – Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development No Regulatory Education for Industry: Regulated Bioanalysis Workshop: Requirements and Expectations Conference/Workshop 6/30/2020 Generic Drug Development No What Meta-analysis Can Tell You about the Performance of Bioanalytical Methods – Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development No Keynote: Pharmaceutical Quality: A Global Priority (CDER) (1/15) Global Quality Webinar 7/23/2020 Drug Quality; International No An International Commitment to Pharmaceutical Quality (2/15) Global Quality Webinar 7/23/2020 Drug Quality; International No Manufacturing Assessment and Application Action (3/15) Global Quality Webinar 7/23/2020 Drug Quality; International No Pre-Approval Inspections and Alternative Approaches to Facility Assessment (4/15) Global Quality Webinar 7/23/2020 Drug Quality; Inspections; International No An Overview of Pre-License Inspections for Biotech Products (5/15) Global Quality Webinar 7/23/2020 Drug Quality; Inspections; International No Panel Discussion (6/15) Global Quality Webinar 7/23/2020 Drug Quality; Inspections; International No FDA’s International Mission and the Global Manufacturing Landscape (7/15) Global Quality Webinar 7/23/2020 Drug Quality; International No Quality Management Maturity: FDA Vision & Expectations (8/15) Global Quality Webinar 7/23/2020 Drug Quality; International No Major Issues and Facilities in Drug Master Files (9/15) Global Quality Webinar 7/23/2020 Drug Quality; Drug Master Files; International No Pharmaceutical Quality Policies: What You Need to Know (10/15) Global Quality Webinar 7/23/2020 Drug Quality; International No Panel Discussion (11/15) Global Quality Webinar 7/23/2020 Drug Quality; Drug Master Files; International No FDA’s International Office and the Pharmaceutical Quality Mission (12/15) Global Quality Webinar 7/23/2020 Drug Quality; International No The State of Pharmaceutical Quality: Surveillance Findings (13/15) Global Quality Webinar 7/23/2020 Drug Quality; International No Successfully Implementing Advanced Manufacturing (14/15) Global Quality Webinar 7/23/2020 Drug Quality; International No Panel Discussion (15/15) Global Quality Webinar 7/23/2020 Drug Quality; International No A Pharmaceutical Quality Webinar for Global Stakeholders Webinar 7/23/2020 Drug Quality; International No CDER SEND Common Issues and Policy Update Webinar 6/15/2020 Regulatory Submissions No Best Practices for Proprietary Name Design – Pharmacovigilance   Conference/Workshop 6/9/2020 Safety No Combination Products: Reporting Device Information and Malfunctions – Pharmacovigilance   Conference/Workshop 6/9/2020 Safety No Considerations for REMS Surveys and Assessments: Planning and Reporting – Pharmacovigilance   Conference/Workshop 6/9/2020 Safety No Designing User Interfaces to Prevent Medication Errors – Pharmacovigilance   Conference/Workshop 6/9/2020 Safety No Development of Shared System REMS & Implications of the Appropriations Act – Pharmacovigilance   Conference/Workshop 6/9/2020 Safety No Digital IND Safety Reporting – Pharmacovigilance   Conference/Workshop 6/9/2020 Safety; IND No Division of Risk Management: Overview of Review Activities and REMS – Pharmacovigilance   Conference/Workshop 6/9/2020 Safety No FDA Adverse Event Reporting System (FAERS) Overview – Pharmacovigilance   Conference/Workshop 6/9/2020 Safety No FDA’s Sentinel Initiative – Pharmacovigilance   Conference/Workshop 6/9/2020 Safety No ICSR Data Quality of Coding: Products, Adverse Events and Medication Errors – Pharmacovigilance   Conference/Workshop 6/9/2020 Safety No Keynote – Pharmacovigilance and Risk Management Conference   Conference/Workshop 6/9/2020 Safety No Postmarket Safety Surveillance: Tools, Methods, and Benefit-Risk Framework – Pharmacovigilance   Conference/Workshop 6/9/2020 Safety No Preventing Medication Errors: Lessons Learned from Postmarket Safety Surveillance– Pharmacovigilance Conference/Workshop 6/9/2020 Safety No Process for Reviewing Nonproprietary Name Suffix for Biological Products – Pharmacovigilance   Conference/Workshop 6/9/2020 Safety No Questions and Discussion – Pharmacovigilance   Conference/Workshop 6/9/2020 Safety No REMS Integration Initiatives – Pharmacovigilance   Conference/Workshop 6/9/2020 Safety No Pharmacovigilance and Risk Management Conference – New Approaches, Tools, and Technologies Conference/Workshop 6/9/2020 Drug Development; Drug Safety No Monograph reform is here! Learn what to expect and how to prepare. Webinar 5/29/2020 Regulatory Submissions; OTC Drug Regulation No Still submitting paper to CDER? Send electronically with CDER’s NextGen Portal instead! Webinar 5/26/2020 Regulatory Submissions No Conducting Clinical Trials During the COVID-19 Public Health Emergency Webinar 4/30/2020 New Drug Development No Postmarketing Drug Safety Compliance: 2019 Inspection Findings  Webinar 4/29/2020 Safety; Inspections No Updates on FDA’s Drug-Drug Interaction Final Guidances Webinar 4/24/2020 New Drug Development; IND No Generic Drugs Forum – April 15&16, 2020 Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality No ANDA Program Performance Review and Tips (8/16) Generic Drugs Forum Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality No Application Case Studies on FDA’s Action Letter Timing (16/16) Generic Drugs Forum Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality No Common CMC (Quality) Issues and How to Avoid Them Part I (12/16) Generic Drugs Forum Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality No Common CMC (Quality) Issues and How to Avoid Them Part II (14/16) Generic Drugs Forum Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality No Current Global Generic Drug Landscape (10/16) Generic Drugs Forum Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality No Electronic Submission of an ANDA Application and Study Data (7/16) Generic Drugs Forum   Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality No Facility Readiness: GMPs, Quality Assessments, and Compliance Trends (15/16) Generic Drugs Forum  Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality No Generic Combination Products: Assessment and Regulatory Update (14/16) Generic Drugs Forum Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality No Generic Drug Labeling: Recommendations for High-Quality Submissions (4/28) Generic Drugs Forum Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality No ICH Q12 Guidance and Emerging Technology Program (11/16) Generic Drugs Forum Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality No Keynote from the Office of Pharmaceutical Quality (OPQ) (2/16) Generic Drugs Forum Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality No Keynote: Generic Drug Program Update (1/16) Generic Drugs Forum Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality No New Programs and Requirements Under FDARA (5/16) Generic Drugs Forum Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality No Pre-ANDA Interactions with the FDA (6/16) Generic Drugs Forum Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality No Product Specific Guidances (PSGs) (3/16) Generic Drugs Forum Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality No The Importance of Generic Drug Pharmacovigilance (9/16) Generic Drugs Forum Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality No Learn About ClinicalTrials.gov Modernization and How to Provide Input Webinar 3/6/2020 Clinical Trials and Research No Recent Revisions to the ANDA Prioritization MAPP Webinar 1/30/2020 Generic Drug Development No Improving Regulatory Communication via the CDER NextGen Portal SBIA Chronicles Podcast 12/29/2019 Regulatory Submissions No Improving Regulatory Communication via the CDER NextGen Portal SBIA Chronicles 12/19/2019 Regulatory Submissions No 2019 CDER Prescription Drug Labeling Conference – December 4-5, 2019 Conference/Workshop 12/4/2019 New Drug Development; Labeling No A Recipe for Clinical Pharmacology Information in Labeling (1/19) Conference/Workshop 12/4/2019 Labeling No Adverse Reaction Information in Prescribing Information (3/19) Conference/Workshop 12/4/2019 Labeling No Drug Product Nomenclature (15/19) Conference/Workshop 12/4/2019 Labeling No Improving the Accuracy of SPL Submissions “The Missing LOINC” (9/19) Conference/Workshop 12/4/2019 Labeling No Indications and Usage & Drug Abuse and Dependence Sections of Labeling (2/19) Conference/Workshop 12/4/2019 Labeling No Instructions for Use (IFU) Content and Format Draft Guidance (13/19) Conference/Workshop 12/4/2019 Labeling No Labeling Case Study: Transformation of an Indication (6/19) Conference/Workshop 12/4/2019 Labeling No Labeling Finalization: Final Check of Prescribing Information (8/19) Conference/Workshop 12/4/2019 Labeling No Labeling for Biological Products (11/19) Conference/Workshop 12/4/2019 Labeling No Panel Questions and Discussion (10/19) Conference/Workshop 12/4/2019 Labeling No Panel Questions and Discussion (16/19) Conference/Workshop 12/4/2019 Labeling No Panel Questions and Discussion (19/19) Conference/Workshop 12/4/2019 Labeling No Panel Questions and Discussion (7/19) Conference/Workshop 12/4/2019 Labeling No Pediatric Information In Prescribing Information (4/19) Conference/Workshop 12/4/2019 Labeling No Prescribing Information and Carton/Container Labeling Consistency (18/19) Conference/Workshop 12/4/2019 Labeling No Product Title & Initial US Approval in the Highlights Section (14/19)    Conference/Workshop 12/4/2019 Labeling No Safety Considerations for Container Labels and Carton Labeling (17/19) Conference/Workshop 12/4/2019 Labeling No The Pregnancy and Lactation Labeling Rule: Four Years In — What’s next? (5/19) Conference/Workshop 12/4/2019 Labeling No Voluntary PLR Conversions and Updating Prescribing Information (1/19) Conference/Workshop 12/4/2019 Labeling No 2019 CDER Prescription Drug Labeling Conference Conference/Workshop 12/4/2019 Labeling No FDA Study Data Technical Conformance Guide v4.4 Webinar 11/22/2019 Regulatory Submissions No Clinical Investigator Training Course Conference/Workshop 11/12/2019 New Drug Development No Technical Specifications for Submitting Data for QT Studies Webinar 11/8/2019 Regulatory Submissions No Submitting IND Safety Reports to FDA Adverse Event Reporting System (FAERS) Webinar 11/1/2019 Safety; IND; Regulatory Submissions No OPDP Electronic Submissions – Common Errors in eCTD and How to Avoid Them Webinar 10/25/2019 Regulatory Submissions; Marketing No Compliance Program and Case Study (7/8) Registration and Listing Conference/Workshop 10/22/2019 Registration and Listing No Electronic Drug Registration and Listing Using CDER Direct Conference/Workshop 10/22/2019 Registration and Listing No Establishment Registration and Labeler Code Requests (3/8) Registration and Listing Conference/Workshop 10/22/2019 Registration and Listing No Keynote from the Drug Registration and Listing Staff (2/8) Registration and Listing Conference/Workshop 10/22/2019 Registration and Listing No Listing Certification and Inactivation (6/8) Registration and Listing Conference/Workshop 10/22/2019 Registration and Listing No NDC Reservation, Listing, 503B Compounded Product (5/8) Registration and Listing Conference/Workshop 10/22/2019 Registration and Listing No Panel Questions and Discussion (4/8) Drug Registration and Listing Using CDER Direct Conference/Workshop 10/22/2019 Registration and Listing No Panel Questions and Discussion (8/8) Registration and Listing Conference/Workshop 10/22/2019 Registration and Listing No Welcome from CDER’s Office of Compliance (1/8) Registration and Listing  Conference/Workshop 10/22/2019 Registration and Listing No Application Manufacturing Assessment (4/33) Quality Conference/Workshop 10/16/2019 Drug Quality No Assessment of the Multi-Attribute Method (MAM) Substance (23/33) Quality Conference/Workshop 10/16/2019 Drug Quality No Biosimilars and Interchangeables – Regulatory Highlights (27/33) Quality Conference/Workshop 10/16/2019 Drug Quality No Case Studies: Continuous Manufacturing of Drug Substance (21/33) Quality Conference/Workshop 10/16/2019 Drug Quality No Change Management: ICH Q12 and Established Conditions (12/33) Quality Conference/Workshop 10/16/2019 Drug Quality No Continuous Manufacturing of Drug Product (20/33) Quality Conference/Workshop 10/16/2019 Drug Quality No Data Quality Expectations for Biosimilars with Case Studies (29/33) Quality Conference/Workshop 10/16/2019 Drug Quality No Emerging Technology Program (18/33) Quality Conference/Workshop 10/16/2019 Drug Quality No End-to-end Integrated Continuous Manufacturing (25/33) Quality Conference/Workshop 10/16/2019 Drug Quality No FDA Perspectives on Biosimilar BLA-Manufacturing (28/33) Quality Conference/Workshop 10/16/2019 Drug Quality No FDA Research Supporting Emerging Technologies with Case Studies (24/33) Quality Conference/Workshop 10/16/2019 Drug Quality No FDA’s Quality Assessment and Knowledge Management – KASA (11/33) Quality Conference/Workshop 10/16/2019 Drug Quality No How Does FDA Execute Pre- and Post-approval Inspections? (7/33) Quality Conference/Workshop 10/16/2019 Drug Quality No Integration of Assessment and Inspection for Biological Products (9/33) Quality Conference/Workshop 10/16/2019 Drug Quality No Keynote: CDER’s Commitment to Pharmaceutical Quality (1/33) Quality Conference/Workshop 10/16/2019 Drug Quality No Panel Questions and Discussion (10/33) Quality Conference/Workshop 10/16/2019 Drug Quality No Panel Questions and Discussion (13/33) Quality Conference/Workshop 10/16/2019 Drug Quality No Panel Questions and Discussion (17/33) Quality Conference/Workshop 10/16/2019 Drug Quality No Panel Questions and Discussion (22/33) Quality Conference/Workshop 10/16/2019 Drug Quality No Panel Questions and Discussion (26/33) Quality Conference/Workshop 10/16/2019 Drug Quality No Panel Questions and Discussion (30/33) Quality Conference/Workshop 10/16/2019 Drug Quality No Panel Questions and Discussion (33/33) Quality Conference/Workshop 10/16/2019 Drug Quality No Panel Questions and Discussion (6/33) Quality Conference/Workshop 10/16/2019 Drug Quality No Pharmaceutical Quality Surveillance Program (14/33) Quality Conference/Workshop 10/16/2019 Drug Quality No Pharmaceutical Quality Symposium  Conference/Workshop 10/16/2019 Drug Quality No Policy Considerations for Continuous Manufacturing (19/33) Quality Conference/Workshop 10/16/2019 Drug Quality No Policy Initiatives for Pharmaceutical Quality (5/33) Quality   Conference/Workshop 10/16/2019 Drug Quality No Quality Assessment of BLAs, NDAs, and ANDAs (3/33) Quality   Conference/Workshop 10/16/2019 Drug Quality No Quality Considerations for Transition Biological Products (32/33) Quality   Conference/Workshop 10/16/2019 Drug Quality No Quality Metrics, Quality Culture, and Data-Driven Decisions (16/33) Quality   Conference/Workshop 10/16/2019 Drug Quality No Quality-Related Compliance Actions and Trends (15/33) Quality   Conference/Workshop 10/16/2019 Drug Quality No Small Molecule Case Studies (8/33) Quality   Conference/Workshop 10/16/2019 Drug Quality No The “Deemed to be a License” Provision of the BPCI Act (31/33) Quality   Conference/Workshop 10/16/2019 Drug Quality; Biosimilars; BLA; NDA No The Importance of Quality in Our Medicines (2/33) Quality   Conference/Workshop 10/16/2019 Drug Quality No Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards  Webinar 10/11/2019 Regulatory Submissions; Safety No 2019 Complex Generic Drug Product Development Workshop Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No BE Approaches for Long Acting Drug Products (14/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No BE for Bridging Studies with Orally Inhaled/Nasal Drugs (26/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Bioequivalence for Generic Topical and Transdermal (6/35) Complex Generics  Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No CMC Updates for Orally Inhaled Drugs (27/35) Complex Generics  Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Comparative Analyses: Device and User Interface (25/35) Complex Generics  Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Comparative Analyses: Injectable Combination Products (21/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Complex Peptide ANDAs: Test/Reference Comparability (11/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Considerations of Particle Analysis (12/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No CREdIbility for Computational Fluid Dynamics Models (33/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Dose-Scale Analysis in Pharmacodynamic Equivalence (31/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No FDA’s Inactive IngREdIent Database (IID) (3/f35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Generic Topical and Transdermal Products (5/35) Complex Generics  Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No In Vitro Drug Release Testing for LA Drug Products QC (16/35) Complex Generics  Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Keynote with Sally Choe (1/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Overview of Comparative Analyses – Clinical Perspective (19/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Panel Questions and Discussion (35/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Physiologically-based Pharmacokinetic Modeling (32/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No PK/PD Meta-analysis of Abuse Deterrent Opioid Drugs (30/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Pre-ANDA Meeting Requests for Orally Inhaled/Nasal Drugs(24/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Pre-ANDA Program Update (2/35) Complex Generics  Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No PSG Recommendations and Updates for OINDPs (23/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Quality for Transdermal Delivery Systems (8/35) Complex Generic Drugs   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Quality View on Injectable Product Considerations (20/35) Complex Generic Drugs   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Quantitative Clinical Pharmacology in LA Injectables (34/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Quantitative Methods and Modeling (29/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Questions and Answers (13/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Questions and Answers (17/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Questions and Answers (22/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Questions and Answers (28/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Questions and Answers (4/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Questions and Answers (9/35) Complex Generic Drugs   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Strategies for Generic Topical Product Development (7/35) Complex Generics  Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Strategies to Demonstrate Complex API Sameness (10/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No Strategies to Demonstrate Complex Excipient Sameness (15/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No What Constitutes Complex Drug-Device Combination (18/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality No REdI and CERSI Workshop: Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls  Conference/Workshop 9/23/2019 New Drug Development No Abbreviated Approval Pathways – 505(b)(2) or ANDA? SBIA Chronicles 9/19/2019 Generic Drug Development; NDA No Abbreviated Approval Pathways – 505(b)(2) or ANDA? SBIA Chronicles Podcast 9/19/2019 Generic Drug Development; NDA No Most Common Issues with CDISC-SEND Data in FDA Toxicology Review Webinar 9/12/2019 Regulatory Submissions No eCTD Submissions of Promotional Labeling and Advertising Materials Webinar 8/12/2019 Regulatory Submissions; Marketing No Risk-Based Approach to Monitoring Clinical Investigations: Overview of FDA Draft Guidance Issued for Comment Webinar 6/26/2019 Clinical Trials and Research No Research Investigational New Drug Applications – What You Need To Know SBIA Chronicles 6/25/2019 Clinical Trials and Research; IND No Research Investigational New Drug Applications – What You Need To Know SBIA Chronicles Podcast 6/25/2019 Clinical Trials and Research; IND No Bioanalytical Method Validation of ANDAs – What the Assessor Looks for During Inspections Webinar 6/17/2019 Generic Drug Development No Accuracy and Precision in Bioanalysis: Review of Case Studies  Webinar 6/17/2019 New Drug Development No Bioanalytical Method Validation (BMV) Panel Discussion Webinar 6/17/2019 New Drug Development No Bioanalytical Inspections: Overview and Case Studies  Webinar 6/17/2019 New Drug Development No How should I measure this? An FDA perspective on the Bioanalytical Method Validation (BMV) Webinar 6/17/2019 New Drug Development No The Finalized Bioanalytical Method Validation Guidance: What’s New For NDAs and BLAs  Webinar 6/17/2019 New Drug Development; NDA; BLA No Identification of Medicinal Products (IDMP): What is IDMP and Why Should I Care?  Webinar 6/13/2019 New Drug Development No CDER FDA Exclusivity – Which One Is for Me?  Webinar 6/10/2019 User Fees; NDA; BLA No FDA Orphan Drugs Program and Financial Incentives for CDER Medical Products Webinar 6/10/2019 User Fees; NDA; BLA No Financial Incentives for CDER Medical Products Webinar 6/10/2019 User Fees; NDA; BLA No Navigating the World of Biosimilar User Fees Webinar 6/10/2019 BLA; User Fees No Panel on Financial Incentives for CDER Medical Products – PDUFA & Biosimilars  Webinar 6/10/2019 User Fees; NDA; BLA No Prescription Drug User Fee Act Waivers, Exemptions, and Refunds -Oh My Webinar 6/10/2019 User Fees; NDA; BLA No A Medical Officer’s Approach to NDA/BLA Review (8/15) REdI Annual Conference  Conference/Workshop 5/29/2019 New Drug Development; IND; Resources No CDER Industry Assistance Resources (1/15) REdI  Conference/Workshop 5/29/2019 New Drug Development; IND; Resources No CDER’s Review of the Prescribing Information (11/15) REdI– May 29-30, 2019 Conference/Workshop 5/29/2019 New Drug Development; IND No CMC – NDA requirements and Common Pitfalls of BLAs (14/15) REdI  Conference/Workshop 5/29/2019 New Drug Development; IND No Components of New Drug Application and Biologics License Application (5/15) REdI Conference/Workshop 5/29/2019 New Drug Development; IND No Electronic Common Technical Document (eCTD) and Study Data (7/15) REdI  Conference/Workshop 5/29/2019 New Drug Development; IND No Meetings: Pre-submission and Special Programs (4/15) REdI Annual Conference  Conference/Workshop 5/29/2019 New Drug Development; IND No Navigating the World of Combination Products (2/15) REdI  Conference/Workshop 5/29/2019 New Drug Development; IND No NDA and BLA Application Review Process (6/15) REdI Annual Conference  Conference/Workshop 5/29/2019 New Drug Development; IND No Nonproprietary Name Suffix and Safety for Product Design and Labels (10/15) REdI  Conference/Workshop 5/29/2019 New Drug Development; IND No ORA Aligned for the Future (1/15) REdI  Conference/Workshop 5/29/2019 New Drug Development; IND No Pre-Approval Inspections: What to Expect When Being Inspected (15/15) REdI  Conference/Workshop 5/29/2019 New Drug Development; IND; Inspections No Ready to Launch: Essentials of Submitting Initial Materials to OPDP (12/15) REdI Conference/Workshop 5/29/2019 New Drug Development; IND; Marketing No Regulatory Education for Industry (REdI) Annual Conference – Focus on Essentials of NDAs and BLAs Conference/Workshop 5/29/2019 User Fees; NDA; BLA No Regulatory Highlights for Biosimilars and Interchangeables (9/15) REdI  Conference/Workshop 5/29/2019 New Drug Development; IND No What can CDER do for you? (3/15) REdI Annual Conference  Conference/Workshop 5/29/2019 New Drug Development; IND No Competitive Generic Therapies  SBIA Chronicles 5/23/2019 Generic Drug Development No Competitive Generic Therapies SBIA Chronicles Podcast 5/23/2019 Generic Drug Development No An Introduction to FDA MyStudies: An Open-Source, Digital Platform to Gather Real World Data for Clinical Trials and Research Studies  Webinar 5/9/2019 Clinical Trials and Research No Deploying the MyStudies System in a Compliant Manner (8/9) MyStudies App  Webinar 5/9/2019 New Drug Development; Real World Evidence No Final Question and Answer Panel (9/9) MyStudies App Webinar 5/9/2019 New Drug Development; Real World Evidence No Introduction (1/9) FDA MyStudies Mobile App System  Webinar 5/9/2019 New Drug Development; Real World Evidence No Mobile Application and WCP: Usability and Technical Overview (5/9) FDA MyStudies App Webinar 5/9/2019 New Drug Development; Real World Evidence No Patient and Researcher Experiences: A Demonstration (2/9) FDA MyStudies App  Webinar 5/9/2019 New Drug Development; Real World Evidence No Patient and Researcher Experiences: Demo of the FDA MyStudies Mobile App (3/9)  Webinar 5/9/2019 New Drug Development; Real World Evidence No Question and Answer Panel (7/9) MyStudies App  Webinar 5/9/2019 New Drug Development; Real World Evidence No Question and Answer Session Martin and Wyner (4/9) FDA MyStudies App Webinar 5/9/2019 New Drug Development; Real World Evidence No Response Server Technical Overview (6/9) FDA MyStudies App  Webinar 5/9/2019 New Drug Development; Real World Evidence No 505(b)(2) NDA or ANDA? (10/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Assessment Tips (17/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Case Studies: Inadequate Bioequivalence Studies (18/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Complex Product Development (3/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Continuous Manufacturing with a Generic Perspective (25/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Decrease RTR, IR, and CR Due to Dissolution Deficiencies (21/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Deficiencies and Observations from Facility Evaluations and Inspections(27/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Drug Master Files (DMFs) from an ANDA Perspective (7/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Filing and Refuse to Receive (RTR) (16/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Generic Drug Forum: April 3-4, 2019 Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Impurity Case Studies: Pharmacology/Toxicology (22/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Keynote: Generic Drug Program Update (1/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Manufacturing Process and Controls: Avoiding Assessment Issues (26/28) Generic Drug Forum   Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Mid-cycle Assessment and Post-complete Response Letter Meetings (6/28) Generic Drug Forum Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Orange Book – Its Role in ANDAs (8/28) Generic Drug Forum Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Practical Tips on eCTD (13/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Pre-ANDA Meeting or Controlled Correspondence? (4/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Questions and Answers (11/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Questions and Answers (15/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Questions and Answers (19/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Questions and Answers (23/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Questions and Answers (28/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Questions and Answers (5/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Referencing Approved Drug Products in ANDA Submissions (9/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Stability Case Studies (20/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No The Importance of Quality in Our Medicines (2/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Tips on Using the CDER NextGen Collaboration Portal (12/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Types of Fees and Q&A (24/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No Update on Technical Rejection Criteria for Study Data (14/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality No A New Era for Homeopathic Drug Product Regulation  SBIA Chronicles Podcast 3/22/2019 New Drug Development No Framework for FDA’s Real-World Evidence Program  Webinar 3/15/2019 New Drug Development; Real World Evidence No Human Drug Establishment Registration and Drug Listing Compliance; CDERLearn Course
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CDERLearn Course 3/12/2019 Registration and Listing No FDA Modernizes Clinical Trials with Master Protocols SBIA Chronicles 2/26/2019 New Drug Development; IND; Clinical Trials and Research No FDA Modernizes Clinical Trials with Master Protocols SBIA Chronicles Podcast 2/26/2019 New Drug Development; IND; Clinical Trials and Research No Final Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations  Webinar 12/6/2018 Clinical Trials and Research; Regulatory Submissions No Early Engagement with FDA to Discuss Novel Surrogate Endpoints SBIA Chronicles 11/27/2018 New Drug Development; FDA Meetings/Communications No Early Engagement with FDA to Discuss Novel Surrogate Endpoints  SBIA Chronicles Podcast 11/27/2018 New Drug Development; FDA Meetings/Communications No FDA Study Data Technical Conformance Guide Webinar 11/27/2018 Regulatory Submissions No Clinical Investigator Training Course (CITC) 2018: November 13 – 15, 2018 Conference/Workshop 11/13/2018 New Drug Development; Clinical Trials No FDA Facilitates the Use of Surrogate Endpoints in Drug Development SBIA Chronicles 11/5/2018 Clinical Trials and Research; IND No FDA Facilitates the Use of Surrogate Endpoints in Drug Development  SBIA Chronicles Podcast 11/5/2018 Clinical Trials and Research; IND No A Case Example of the Review of Audit Trails in GCP Inspections (11/11) GCP Data Integrity Workshop Conference/Workshop 10/23/2018 Clinical Trials and Research No Blinding of Bioequivalence Trials (9/11) GCP Data Integrity Conference/Workshop 10/23/2018 Clinical Trials and Research No Data Integrity from International Perspectives (2/11) GCP Data Integrity Workshop Conference/Workshop 10/23/2018 Clinical Trials and Research No Data Quality: Why Do We Care? (1/11) GCP Data Integrity Conference/Workshop 10/23/2018 Clinical Trials and Research No Effective Use of Audit Trails (10/11) GCP Data Integrity Workshop Conference/Workshop 10/23/2018 Clinical Trials and Research No FDA & MHRA Good Clinical Practice Workshop: Data Integrity in Global Clinical Trials – Are We There Yet?: October 23-24, 2018 Conference/Workshop 10/23/2018 New Drug Development; Clinical Trials and Research No Good Clinical Practice Assessment of Data Reliability in Registration Trials (5/11) GCP Data Conference/Workshop 10/23/2018 Clinical Trials and Research No Overview of Data Integrity (4/11) GCP Data Integrity Workshop Conference/Workshop 10/23/2018 Clinical Trials and Research No Quality and Control of Clinical Trial Data (6/11) GCP Data Integrity Workshop Conference/Workshop 10/23/2018 Clinical Trials and Research No Quality Management Systems and Quality By Design (3/11) GCP Data Integrity Workshop Conference/Workshop 10/23/2018 Clinical Trials and Research No The Data Management Plan – Pulling It All Together (7/11) GCP Data Integrity Workshop Conference/Workshop 10/23/2018 Clinical Trials and Research No Unblinding – Let Me Count the Ways… (8/11) GCP Data Integrity Conference/Workshop 10/23/2018 Clinical Trials and Research No Electronic Drug Registration and Listing Using CDER Direct: October 2, 2018 Conference/Workshop 10/2/2018 Registration and Listing No Writing the “Indications and Usage” Section of Labeling: FDA’s New Draft Guidance  Webinar 9/27/2018 Labeling No Real-Time Review of Drug Applications is Now a Reality SBIA Chronicles 9/20/2018 IND; NDA No Real-Time Review of Drug Applications is Now a Reality SBIA Chronicles Podcast 9/20/2018 IND; NDA No Complex Generic Drug Product Development Workshop Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality No Common Issues in Complex Drug Substance Review (8of39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality No Considerations for Establishing Q1/Q2 Sameness of Complex Formulations (10/39) Complex Generics ’18 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality No Considerations in Demonstrating Complex API Sameness (7/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality No Equivalence testing of complex particle size distribution profiles-earth mover’s distance (15/39) Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality No Establishing Appropriate BE Limits for Complex Formulations (14/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality No In vitro bioequivalence testing for topical ophthalmic suspension products (17/39) Complex Generics Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality No In Vitro Release Testing of Complex Formulations (11/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality No Iron Colloid Drug Products: Characterization and Impurity (13/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality No Multivesicular Liposomes: Physicochemical characterization & in vitro drug release testing (12/39) Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality No Office of Generic Drugs Keynote (1/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality No PBPK modeling and simulation used in assessing BE for generic ophthalmic products (19/39)  Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality No Peptide Drug Challenges through Pre-ANDA Processes & Case Studies (6/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality No Pre-ANDA Logistics and Best Practices (3/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality No Pre-ANDA Program Overview (2/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality No Pre-ANDA review: Office of Pharmaceutical Quality (OPQ) (4/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality No Product Quality Testing for Topical Ophthalmic Suspension Products (18/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality No Questions and Panel Discussion (16/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality No Questions and Panel Discussion (20/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality No Questions and Panel Discussion (5/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality No Questions and Panel Discussion (9/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality No Complex Generic Drug Product Development Workshop – September 12-13, 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality No The FAERS Public Dashboard and its Value to the Pharmaceutical Industry  SBIA Chronicles 7/10/2018 Safety No The FAERS Public Dashboard and its Value to the Pharmaceutical Industry SBIA Chronicles Podcast 7/10/2018 Safety No Postmarketing Drug Safety and Inspection Readiness – June 19, 2018 Deeper Dive Webinar Webinar 6/19/2018 Inspections; Safety; Postapproval No BIMO, REMS, and PADE Inspection Readiness (3/3) Webinar 6/19/2018 Safety; Inspections; Postapproval No Postmarketing Adverse Drug Experience (PADE) Inspections – (1/3)  Webinar 6/19/2018 Safety; Inspections; Postapproval No Risk Evaluation and Mitigation Strategies (REMS) Inspections (2/3)  Webinar 6/19/2018 Safety; Inspections; Postapproval No Benefit-Risk Considerations During Drug Product Development (8/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA No CDER Small Business and Industry Assistance Overview (12/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA; Resources No Chemistry, Manufacturing, and Controls (CMC) for an IND (7/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA No Demystifying the Investigational New Drug (IND) Application for Drugs and Biologics (3/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA No FDA Regulatory Requirements for Clinical Investigators and Case Examples (9/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA No Formal Meetings for PDUFA Products and Communication Best Practices (4/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA No Good Manufacturing Practices (GMPs) from an IND Perspective (11/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA No Human Factors Engineering in Medical Products Reviews (2/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA No Investigational New Drug (IND) Submission: Content/Format and First 30 Days (5/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA No Investigational New Drug Safety Reporting Requirements (10/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA No Nonclinical Safety Assessment for Small Molecules and Biologic Drug Development (6/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA No Office of Regulatory Affairs Update (1/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA No Panel Discussion (27/27) Generic Drugs Forum April 11-12, 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA No The Active IND and Available Development Programs (13/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA No Walkthrough of a Pre-Approval Manufacturing Site Inspection (14/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA No Regulatory Education for Industry (REdI) Spring Conference:  May 15-16, 2018 Conference/Workshop 5/15/2018 New Drug Development; IND No Optimizing Your Data Submissions to FDA: Office of Vaccines Research and Review (OVRR) Data Submission Webinar 5/8/2018 Regulatory Submissions No Updates to Forms 356h & 1571: Commercial vs. Research Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) Combination Products Webinar 5/4/2018 Regulatory Submissions No ANDA Performance/Operations Update (3/27) Generic Drugs Forum April 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality No Application Communications: RBPM Communication with Industry throughout the IQA (24/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality No Best Practices for Conducting Bioequivalence Studies (16/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality No Bioequivalence Site and Manufacturing Facility Information in Applications (17/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality No Challenges in Generic Drug Safety and Surveillance (6/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality No Determining Whether to Submit an ANDA or a 505(b)(2) Application (12/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality No Drug Substance Quality Assessment: Best Practices (23/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality No Electronic Submissions (7/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Regulatory Submissions No Filing Review Basics – Examples of Refuse-to-Receive (RTR) (15/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality No GDUFA II – Review Timelines (14/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality No GDUFA II Pre-ANDA Program Meetings: Advice for Success (10/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality; FDA Meetings/Communications No GDUFA II User Fees: Update on Year One (21/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality No Generic Drug Product Quality Assessment (22/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality No Generic Drugs Forum: April 11 -12, 2018 Conference/Workshop 4/11/2018 Generic Drug Development No Good ANDA Submission and Assessment Practices and Software Support (5/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality No Integrated Process and Facilities Assessment (26/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality No Integrated Quality Assessment Process (19/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality No Keynote Address by Dr. Uhl (1/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality No Laboratory Science to Support Risk-Based Quality Assessments (25/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality No Microbiology Quality Assessment (18/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality No Office of Pharmaceutical Quality (OPQ) Policy Update (4/27) Generic Drugs Forum April 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality No Orange Book: 101 An Overview (11/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality No Panel Discussion (13/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality No Panel Discussion (20/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality No Panel Discussion (9/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality No Pharmaceutical Quality Update by Dr. Michael Kopcha (2/27) Generic Drugs Forum April 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality No Using the ePortal to Submit a pre-ANDA Meeting (8/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality No A New Era for Homeopathic Drug Product Regulation SBIA Chronicles 3/22/2018 New Drug Development No A New Era for Homeopathic Drug Product Regulation SBIA Chronicles Podcast 3/22/2018 New Drug Development No FDA Helping the Generic Industry Submit Complete Applications SBIA Chronicles 2/6/2018 Generic Drug Development; Regulatory Submissions No FDA Helping the Generic Industry Submit Complete Applications SBIA Chronicles Podcast 2/6/2018 Generic Drug Development; Regulatory Submissions No Draft guidance for Industry: Information Requests and Discipline Review Letters Under GDUFA Webinar 12/18/2017 Generic Drug Development; Regulatory Submissions No REMS Integration Initiative: An Overview Webinar 12/4/2017 Safety No PDUFA VI – A Time for Change SBIA Chronicles 11/28/2017 User Fees; NDA  No PDUFA VI – A Time for Change  SBIA Chronicles Podcast 11/28/2017 User Fees; NDA  No Optimizing Your Study Data Submissions to FDA –Study Data Technical Conformance Guide October 2017 Version Update Webinar 11/8/2017 Regulatory Submissions No Prescription Drug Labeling Conference 2017 Conference/Workshop 11/2/2017 Labeling No Draft Guidance for Industry: Controlled Correspondence Related to Generic Drug Development Webinar 11/2/2017 Generic Drug Development No PLR Implementation, CDER Staff for Labeling Review, and Resources (1/9) Prescription Drug Labeling 2017 Conference/Workshop 11/2/2017 Labeling No Consistency, Optimizing Communication, and Best Labeling Practices (2/9) Prescription Drug Labeling 2017 Conference/Workshop 11/2/2017 Labeling No Considerations for Developing the Indications and Usage Section of Labeling (3/9) Labeling 2017 Conference/Workshop 11/2/2017 Labeling No Converting Labeling for Older Drugs from the Old Format to the PLR Format (4/9) Prescription Drug Labeling 2017 Conference/Workshop 11/2/2017 Labeling No Novel and Adaptive Labeling Approaches: PLR and Beyond (5/9) Labeling 2017 Conference/Workshop 11/2/2017 Labeling No Cracking the Code for Clinical Pharmacology-Related Prescription Drug Labeling (6/9) Prescription Drug Labeling 2017 Conference/Workshop 11/2/2017 Labeling No Overview of SPL and Challenges with Medication Guide Extraction and Data Mining (7/9)Prescription Drug Labeling 2017 Conference/Workshop 11/2/2017 Labeling No Lessons Learned with the Pregnancy and Lactation Labeling Rule (PLLR) (8/9) Prescription Drug Labeling 2017 Conference/Workshop 11/2/2017 Labeling No Safety Considerations for Patient Instructions to Minimize Medication Errors (9/9) Labeling 2017 Conference/Workshop 11/2/2017 Labeling No Draft Guidance for Industry: Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA Webinar 11/1/2017 Generic Drug Development; FDA Meetings/Communications No Draft Guidance for Industry: Determining Whether to Submit an ANDA or 505(b)(2) Application Webinar 10/13/2017 Generic Drug Development; NDA No Electronic Drug Registration & Listing Using CDER Direct: Extended Webinar Webinar 10/5/2017 Registration and Listing No Draft Guidance for Industry: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Webinar 10/2/2017 Generic Drug Development; FDA Meetings/Communications No Regulatory Education for Industry (REdI): Fall Conference: September 27-28, 2017 Conference/Workshop 9/27/2017 New Drug Development; IND No Keynote (1/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND No Plenary: Regulatory Research at FDA (2/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND No Introduction to Investigational New Drug (IND) Applications (3/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND No FDA Communication During Drug Development (4/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND; FDA Meetings/Communications No Regulatory and Administrative Components of an IND Application (5/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND; Regulatory Submissions No Benefit-Risk Considerations in Drug Development (6/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND No Chemistry, Manufacturing Controls (CMC) in an Investigational New Drug (IND) (7/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND; Drug Quality No Overview of Non-clinical Assessment in Drug Development (8/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND No Submit Your Investigational New Drug (IND) Application and Clinical Holds (9/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND; Regulatory Submissions No Additional Sponsor Responsibilities (10/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND No Overview of Clinical Investigator Responsibilities and Inspectional Findings (11/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND No Walkthrough of an FDA Clinical Investigator Site Inspection (12/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND; Inspections No Overview of FDA’s Expanded Access Program (13/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND No Live Demo of the FDA Adverse Events Reporting System (14/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND; Drug Safety No Real-World Data and Evidence in Drug Development  SBIA Chronicles 8/24/2017 New Drug Development No Electronic Common Technical Document (eCTD): CDERLearn Course
Certificates of completion and embedded videos are no longer available. CDERLearn Course 8/3/2017 Regulatory Submissions No Optimizing Your Study Data Submissions to FDA – Updates from CDER and CBER  Webinar 7/13/2017 Regulatory Submissions No Updates to the Study Data Technical Conformance Guide (1/4) Technical Conformance  Webinar 7/13/2017 Regulatory Submissions No Providing Clinical Study Data to the Office of Vaccines (2/4) Tech Conformance   Webinar 7/13/2017 Regulatory Submissions No Biologics Quality Bioresearch and Study Data Submissions (3/4) Technical Conformance  Webinar 7/13/2017 Regulatory Submissions No Panel Questions and Discussion (4/4) Study Data Technical Conformance Webinar   Webinar 7/13/2017 Regulatory Submissions No Draft Guidance for Industry: ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA II II Webinar 7/5/2017 Generic Drug Development; Regulatory Submissions No Presenting Clinical Pharmacology Information in Prescription Drug Labeling  Webinar 6/19/2017 Labeling No Risk Evaluation and Mitigation Strategies (REMS): A Deeper Dive Webinar 6/15/2017 New Drug Development; Safety No REMS Purpose, Process, and Challenges (1/2) REMS Webinar  Webinar 6/15/2017 New Drug Development; Safety No Structured Product Labeling Format: An Introduction (2/2) REMS Webinar  Webinar 6/15/2017 New Drug Development; Safety; Regulatory Submissions No Submitting Master Files in eCTD Format: When and How to Comply SBIA Chronicles  5/25/2017 Drug Master Files; Regulatory Submissions No Submitting Master Files in eCTD Format: When and How to Comply  SBIA Chronicles Podcast 5/25/2017 Drug Master Files; Regulatory Submissions No Regulatory Education for Industry (REdI): Spring Conference: May 9-10, 2017 Conference/Workshop 5/9/2017 New Drug Development; IND No The Complexities of Compounding  SBIA Chronicles  4/20/2017 Compounding No The Complexities of Compounding SBIA Chronicles Podcast 4/20/2017 Compounding No Generic Drugs Forum: April 4-5, 2017 Conference/Workshop 4/4/2017 Generic Drug Development No Keynote – Office of Generic Drugs (1/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development No Keynote – Office of Pharmaceutical Quality (2/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Drug Quality No ANDA Performance/Operations Update (3/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development No Office of Pharmaceutical Quality Policy Update (4/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Drug Quality No GDUFA Regulatory Science Research Update (5/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development No Preparing for GDUFA II User Fees (6/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development No eCTD (7/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Regulatory Submissions No Panel Discussion (8/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Regulatory Submissions; Drug Quality No GDUFA II (9/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; User Fees No Development of Single, Shared System REMS (10/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Drug Safety No Introduction to “The ANDA Review Pathway” (11/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development No ANDA Policy and Regulatory Considerations Prior to Filing (12/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development No Panel Discussion (13/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development No Filing Review – Do’s and Don’ts (14/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Regulatory Submissions No RPM Communications Associated with “Take Action” Process (15/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development No FDA’s Bioequivalence Recommendations for Generic Drugs (16/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development No Review of Clinical Endpoint Bioequivalence Studies in ANDAs (17/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development No Generic Labeling: Strategies for Providing High-quality Submissions (18/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Labeling No Panel Discussion (19/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development No OPQ Integrated Quality Assessment (IQA) Process (20/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Drug Quality No OPQ Communications with Industry (21/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Drug Quality No Drug Substance Review – ANDA (22/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Drug Quality No Generic Drug Product Quality Review (23/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Drug Quality No Dissolution Method Development for Generic Drugs (24/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Drug Quality No Manufacturing Process and Controls (25/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Drug Quality No Facility Evaluation and Inspection (26/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Drug Quality; Inspections No Product Quality Microbiology Assessment (27/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Drug Quality No Panel Discussion (28/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Drug Quality; Inspections No CDER Microbiology Issues: A Deeper Dive Webinar 3/15/2017 Drug Quality No Microbiology Assessment: Recommendations for Nonsterile Products (1/6) Microbiology Webinar Webinar 3/15/2017 Drug Quality No Case Study: Micro Investigation of Contamination by Burkholderia multivorans (2/6) Microbiology Webinar Webinar 3/15/2017 Drug Quality No Panel Questions and Discussion (3/6) CDER Microbiology Webinar  Webinar 3/15/2017 Drug Quality No Building a Better Sterility Assurance Application (4/6) CDER Microbiology Webinar  Webinar 3/15/2017 Drug Quality No Aseptic Processing of Biological Products: Regulatory Issues (5/6) Microbiology Webinar Webinar 3/15/2017 Drug Quality No Panel Questions and Discussion (6/6) CDER Microbiology Webinar  Webinar 3/15/2017 Drug Quality No Draft Guidance for Industry: Referencing Approved Drug Products in ANDA Submissions Webinar 3/6/2017 Generic Drug Development No Best Practices for Communication Between FDA and IND Sponsors During Drug Development: CDERLearn Course  
Certificates of completion and embedded videos are no longer available. CDERLearn Course 2/1/2017 FDA Meetings/Communications; IND No FDA Addresses Small Business Concerns in GDUFA II  SBIA Chronicles 1/26/2017 Generic Drug Development No FDA Addresses Small Business Concerns in GDUFA II SBIA Chronicles Podcast 1/26/2017 Generic Drug Development No FDA’s Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond: CDERLearn Course  
Certificates of completion and embedded videos are no longer available. CDERLearn Course 6/7/2021 New Drug Development; Safety; Quality  No GDUFA Self-Identification (SPL) Submission – Part 1: CDERLearn Course  
Certificates of completion and embedded videos are no longer available. CDERLearn Course 1/12/2016 Generic Drug Development; Regulatory Submissions No GDUFA Self-Identification (SPL) Submission – Part 2: CDERLearn Course
Certificates of completion and embedded videos are no longer available. CDERLearn Course 1/12/2016 Generic Drug Development; Regulatory Submissions No Overview of the Generic Drug User Fee Amendments of 2012 (GDUFA): CDERLearn Course  
Certificates of completion and embedded videos are no longer available. CDERLearn Course 1/12/2016 Generic Drug Development; User Fees No Case Studies in FDA’s Drug Regulatory Processes: CDERLearn Course  
Certificates of completion and embedded videos are no longer available. CDERLearn Course 10/22/2015 New Drug Development; NDA; IND No Engaging with the FDA During New Drug Development  
Certificates of completion and embedded videos are no longer available. CDERLearn Course 9/26/2014 New Drug Development; FDA Meetings/Communications No Chemistry, Manufacturing, and Controls (CMC) Perspective of the IND: CDERLearn Course  
Certificates of completion and embedded videos are no longer available. CDERLearn Course 9/17/2014 New Drug Development; Drug Quality No CDER Presentations Library Webinar   New Drug Development; Generic Drug Development; Biosimilars; Clinical Trials and Research No CDER Webinars Webinar   New Drug Development; Generic Drug Development; Biosimilars; Clinical Trials and Research No Guidance Webinar Series Webinar   New Drug Development; Generic Drug Development; Biosimilars; Clinical Trials and Research No

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