Center for Drug Evaluation and Research (CDER) CDERLearn Training

What Does FDA Approve? Part 2 Drug Safety; MedWatch No 0 Is It Really ‘FDA Approved’? Compounding; Drug Development; Drug Regulatory Process; Drug Safety No 0 10 Facts about What FDA Does and Does Not Approve CBD; Compounding; Drug Development; Drug Regulatory Process; Drug Safety No 0 Sunscreen: How to Help Protect Your Skin from the Sun Sunscreen No 0 Facts about Sunscreen Sunscreen No 0 Medicamentos Drug Development; Drug Regulatory Process; Drug Safety; Español No 0 Datos acerca de los medicamentos genéricos Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Español No 0 Hechos Sobre Los Medicamentos Genericos Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Español No 0 Medicamentos Genéricos: Preguntas y Respuestas Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Español No 0 2024 PDA/ FDA Joint Regulatory Conference Drug Development; Drug Regulatory Process; Drug Safety No 0 Complex Innovative Trial Design Meeting Program Case Study; Drug Development; Drug Regulatory Process; Drug Safety No 0 FDA approval of Ojemda (tovorafenib) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0 Conversations on Cancer—Strength in Numbers: Increasing Cancer Awareness While Decreasing Disparities Cancer Drugs; Drug Regulatory Process; Drug Development; Drug Safety; Minority Health No 0 Conversations on Cancer: ODAC Chronicles – the Past, Present, and Future of Oncology Advisory Committees Cancer Drugs; Drug Regulatory Process; Drug Development; Drug Safety No 0 Considerations for Drug Products that Contain Nanomaterials Drug Regulatory Process; Drug Development; Drug Safety No 0 Compounding Quality Center of Excellence | Engage with the Compounding Quality Center of Excellence Compounding; Drug Development; Drug Regulatory Process; Drug Safety No 0 Opioid Use Disorder, New Biosimilar, Black Family Cancer Awareness Week, & more Biosimilars; Cancer Drugs; Drug Regulatory Process; Drug Development; Drug Safety; Minority Health, Opioids No 0 The Role of Artificial Intelligence in Clinical Trial Design and Research with Dr. ElZarrad Drug Development; Drug Regulatory Process; Drug Safety; Artificial Intelligence Yes 0.5 Practitioners’ Guide for Improving Oral Anticoagulant Use Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0 14th Annual Sentinel Initiative Public Workshop COVID-19; Drug Regulatory Process; Drug Development; Drug Safety No 0 2024 Compounding Quality Center of Excellence Annual Conference Compounding; Drug Development; Drug Regulatory Process; Drug Safety Yes 3 6 Tip-Offs to Rip-Offs: Don’t Fall for Health Fraud Scams Drug Safety; Health Fraud No 0 Accelerating Access to Critical Therapies for ALS Drug Development; Drug Regulatory Process No 0 Accelerating Rare disease Cures (ARC) Program Drug Development; Drug Regulatory Process; Rare Diseases No 0 Achieving Data Quality and Integrity in Maximum Containment Laboratories Drug Development; Drug Regulatory Process; Drug Safety No 0 Advancing Generic Drug Development: Translating Science to Approval 2023 Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0 Advancing Regulatory Science at FDA Drug Development; Drug Regulatory Process No 0 Advancing Transparency and Regulatory Science Activities on the Risk Evaluation and Mitigation Strategy (REMS) Drug Regulatory Process; Drug Development; Drug Safety Yes 1 Adverse Events Associated with Compounded Drugs from Outsourcing Facilities Case Study; Compounding; Drug Development; Drug Regulatory Process; Drug Safety; MedWatch No 0 Airflow Compounding; Drug Development; Drug Regulatory Process; Drug Safety Yes 4 Application of Artificial Intelligence and Machine Learning for Precision Medicine Drug Development; Drug Regulatory Process; Drug Safety; Artificial Intelligence No 0 Are you on a biologic medication? What you need to know about biosimilar treatment options Biosimilars No 0 Areas of Customer Need for Outsourcing Facility Products Compounding; Drug Development; Drug Regulatory Process; Drug Safety No 0 Aseptic Process Simulations (Media Fills) Compounding; Drug Development; Drug Regulatory Process; Drug Safety Yes 2 Bench to Bedside: Integrating Sex and Gender to Improve Human Health Drug Development; Drug Regulatory Process; Drug Safety; Women’s Health Yes 1 BeSafeRx: Your Source for Online Pharmacy Information Drug Safety: Health Fraud No 0 Biological Products, Biosimilars Products, and Interchangeable Biosimilar Products Biosimilars; Drug Regulatory Process; Drug Development No 0 Biosimilar and Interchangeable Biologics: More Treatment Choices Biosimilars No 0 Biosimilar and Interchangeable Biosimilars: Review of Scientific Concepts, Case Studies, and Resources Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety Yes 1 Biosimilar Basics Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0 Biosimilar Basics for Patients Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0 Biosimilar Manufacturing and Variation Biosimilars; Drug Regulatory Process; Drug Development No 0 Biosimilar Medications – What Health Care Providers Need to Know Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety No 0 Biosimilar Medications – What Patients Need to Know Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety No 0 Biosimilar Regulatory Approval Pathway Biosimilars; Drug Regulatory Process; Drug Development No 0 Biosimilares: Lo que los pacientes con diabetes deben saber Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Español No 0 Biosimilares: Lo que los pacientes deben saber Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Español No 0 Biosimilars 101: A Primer for Your Practice Biosimilars; Cancer Drugs; Case Study; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch; Women’s Health Yes 0.25 Biosimilars 102: Interchangeability, Extrapolation, and Immunogenicity – A Regulatory Process Primer (medscape.org) Biosimilars; Drug Regulatory Process; Drug Development Yes 0.25 Biosimilars Basics Infographic Biosimilars; Generic Drugs No 0 Biosimilars Curriculum Materials for Health Care Degree Programs Biosimilars; Case Study; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0 Biosimilars in the Real World: Perspectives for Staying Within the Scope of Care Biosimilars; Cancer Drugs; Case Study; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch Yes 0.5 Biosimilars Level 1: Foundational Concepts Biosimilars; Case Study Drug Regulatory Process; Drug Development No 0 Biosimilars Level 2: Regulatory and Scientific Concepts Case Study No 0 Biosimilars Multimedia Education Materials Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety No 0 Biosimilars Overview for Health Care Professionals Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety No 0 Biosimilars Patient Materials Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety No 0 Biosimilars Resources Biosimilars; Case Study; Drug Regulatory Process; Drug Development No 0 Biosimilars Videos Drug Development; Biosimilars;  Drug Regulatory Process No 0 Biosimilars: A Review of Scientific, Regulatory, and Clinical Considerations for Health Care Providers Biosimilars; Drug Regulatory Process; Drug Development Yes 1 Biosimilars: Are they the same quality? Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety No 0 Biosimilars: What Patients Need to Know Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0 Biosimilars: What Patients With Diabetes Need To Know Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0 Biosimillars Health Care Provider Materials Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety No 0 Bridging Efficacy and Safety to the Obese Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; IND/Expanded Access; MedWatch; Women’s Health No 0 Bringing Clinical Research to Patients  Drug Regulatory Process; Drug Development; Drug Safety Yes 1 Cannabis and Cannabis-Derived Products – For Healthcare Practitioners Drug Regulatory Process; Drug Development; Drug Safety; Cannabidiol Yes 1 CDER Conversation: Improving Medication Adherence and Patient Experience by Researching Patient Perceptions of Generic Drug Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0 CDER Webinars Drug Regulatory Process; Drug Development; Generic Drugs; OTC Drug Regulations; Biosimilars; Drug Safety; MedWatch; IND/Expanded Access; Cancer Drugs No 0 CDER’s Emerging Drug Safety Technology Meeting Program Drug Development; Drug Regulatory Process; Drug Safety; Artificial Intelligence No 0 Cleanroom In-person Course Compounding; Drug Regulatory Process; Drug Development Yes 13.75 Clinical Trial Basics Drug Regulatory Process; Drug Development; Drug Safety; IND/Expanded Access; Women’s Health No 0 Clinical Trial Basics with Dr. Robert Temple Drug Regulatory Process; Drug Development; Drug Safety; IND/Expanded Access; Women’s Health Yes 0.5 Compounding Outsourcing Facilities Annual Study Compounding; Drug Development; Drug Regulatory Process; Drug Safety No 0 Compounding Quality Center of Excellence Annual Conference 2023 Compounding, COVID-19, Drug Development, Drug Regulatory Process, Drug Safety No 0 Compounding Quality Center of Excellence Virtual Conference Compounding; Drug Development; Drug Regulatory Process; Drug Safety No 0 Conceptos ba¡sicos sobre los biosimilares Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Español No 0 Conversation on Paxlovid with Dr. John Farley COVID-19; Drug Regulatory Process; Drug Development; Drug Safety Yes 0.5 Conversations on Cancer, Black History Month Program: Real Talk: Our Stories as Black Oncologists at the FDA Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety, Minority Health No 0 Conversations on Cancer: “What’s on the Horizon: Future of Cancer Care” Cancer Drugs No 0 Conversations on Cancer: Bringing Innovation to People Facing Cancer Cancer Drugs No 0 Conversations on Cancer: Cancer Disparities in Appalachia Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0 Conversations on Cancer: Cancer Misinformation: Truth or Consequences Cancer Drugs, Drug Development, Drug Regulatory Process, Drug Safety No 0 Conversations on Cancer: How Biotech Built a Blockbuster Cancer Drug Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0 Conversations on Cancer: Living with Metastatic Breast Cancer Cancer Drugs No 0 Conversations on Cancer: National Black Family Cancer Awareness Week, Engaging the Generations Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety, Minority Health No 0 Conversations on Cancer: Seasons of Change: Oncology Careers Cancer Drugs No 0 Conversations on Cancer: Transforming Patient Lives by Therapeutic and Regulatory Innovations Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0 Counseling Patients on Generic Drugs Generic Drugs; Drug Regulatory Process; Drug Development; Drug Safety Yes 1 CURE ID, A Tool for Clinicians to Report New Uses of Existing Drugs with Heather Stone and Dr. Marco Schito Case Study; COVID-19; Drug Development; Drug Regulatory Process; Drug Safety; MedWatch Yes 0.5 Development and U.S. Regulation of Preventative Vaccines Drug Regulatory Process; Drug Development Yes 1 Drug Approval Case Studies Case Study; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; IND/Expanded Access No 0 Drug Information Soundcast in Clinical Oncology (D.I.S.C.O) Cancer Drugs; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch; Women’s Health No 0 Drug Shortages with CDR Emily Thakur COVID-19; Drug Development; Drug Regulatory Process; Drug Safety Yes 0.5 Drug Shortages: Root Causes and Potential Solutions Drug Regulatory Process; Drug Development Yes 1 Engaging Providers to Address Knowledge Gaps on Medication Use in Pregnancy and Lactation Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch; Women’s Health Yes 1 Enhanced Drug Distribution Security: 2023 and Beyond Drug Regulatory Process; Drug Safety Yes 1 Environmental Monitoring In-person Course Compounding; Drug Regulatory Process; Drug Development Yes 15.25 Equity of Voices video series Case Study; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch No 0 Expanded Access with Dr. Jacqueline Corrigan-Curay Drug Development; Drug Regulatory Process; Drug Safety; IND/Expanded Access Yes 0.5 FDA 101: An Overview of FDA’s Regulatory Review and Research Activities Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; IND/Expanded Access; OTC Drug Regulations; Women’s Health No 0 FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab) Disease States; Drug Development; Drug Regulatory Process Yes 0.5 FDA approval of Augtyro (repotrectinib) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0 FDA approval of Epkinly (epcoritamab-bysp) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0 FDA approval of Fruzaqla (fruquintinib) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0 FDA approval of Jemperli (dostarlimab-gxly) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0 FDA approval of Keytruda (pembrolizumab) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0 FDA approval of Lynparza (Olaparib) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0 FDA approval of OGSIVEO (nirogacestat) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0 FDA approval of Omisirge (omidubicel-onlv) Cancer Drugs, Drug Development, Drug Regulatory Process, Drug Safety No 0 FDA approval of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0 FDA approval of Polivy (polatuzumab vedotin-piiq) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0 FDA approval of Tafinlar (dabrafenib) with Mekinist (trametinib) for pediatric patients with low-grade glioma with a BRAF V600E mutation Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0 FDA approval of Tibsovo (ivosidenib) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0 FDA approval of Trodelvy (sacituzumab govitecan-hziy) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety; Women’s Health No 0 FDA approval of Verzenio (abemaciclib) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety; Women’s Health No 0 FDA approval of Zynyz (retifanlimab-dlwr) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0 FDA approvals of Jaypirca (pirtobrutinib) and Orserdu (elacestrant) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety; Women’s Health No 0 FDA approvals of Talvey and Elrexfio Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0 FDA approvals of Tukysa (tucatinib) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0 FDA D.I.S.C.O. Burst Edition: Retevmo (selpercatinib) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0 FDA Drug Info Rounds Drug Safety; MedWatch; IND/Expanded Access; Drug Development; Drug Regulatory Process; Generic Drugs No 0 FDA Drug Information Resources and Applicability to Health Care Professionals Drug Regulatory Process; Drug Development; Drug Safety; MedWatch Yes 1 FDA Drug Safety Podcasts Drug Safety Yes 0.5 FDA Drug Topics: The Ins and Outs of Prescription Drug Labeling Drug Regulatory Process; Drug Development; Drug Safety Yes 1 FDA Grand Rounds COVID-19; Drug Regulatory Process; Drug Development; Drug Safety; MedWatch; Generic Drugs; OTC Drug Regulations; Biosimilars; IND/Expanded Access; Cancer Drugs; Women’s Health No 0 FDA Health Playbook Drug Safety; OTC Drug Regulations; MedWatch; Opioids No 0 FDA Insight Compounding; COVID-19; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Opioids; Women’s Health; OTC Drug Regulations No 0 FDA MedWatch and Patient Safety MedWatch; Drug Safety No 0 FDA Office of Clinical Pharmacology and International Society of Pharmacometrics (ISoP) Public Workshop: Using Modeling and Simulation to Select Dosages for Combination Therapies and New Indications Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety; IND/Expanded Access No 0 FDA Overview of Biosimilar Products Biosimilars;Drug Regulatory Process; Drug Development No 0 FDA Rare Disease Day 2023 Drug Development; Drug Regulatory Process; Drug Safety; Rare Diseases No 0 FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds Drug Development; Drug Regulatory Process; Drug Safety; IND/Expanded Access; Cannabidiol No 0 FDA Review and Approval Process for Biosimilar Medications Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety No 0 FDA takes steps to decrease barriers for overdose reversal agents with Dr. Marta Sokolowska Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; OTC Drug Regulations Yes 0.5 FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use Drug Regulatory Process; Drug Safety; Opioids Yes 0.5 FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions Drug Regulatory Process; Drug Development; Drug Safety Yes 0.5 FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan) Drug Regulatory Process; Drug Development; Drug Safety Yes 0.5 FDA/CDER Office of Clinical Pharmacology and International Society of Pharmacometrics (ISoP) Public Workshop: Using Modeling and Simulation to Evaluate the Effects of Intrinsic and Extrinsic Factors Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0 FDA’s Office of Orphan Products Development (OOPD) – An Overview and Update Rare Diseases; Drug Regulatory Process; Drug Development; Drug Safety Yes 1 FDA’s Role in Postmarketing Drug Safety Surveillance Drug Regulatory Process; Drug Development; Drug Safety; MedWatch Yes 1 FDA’s Biomarker Qualification Program Drug Development No 0 FDA’s Overdose Prevention Framework with Dr. Marta Sokolowska Drug Regulatory Process; Drug Development; Drug Safety; MedWatch; Opioids; Cancer Drugs Yes 0.5 FDA’s Regulation of Dietary Supplements with Dr. Cara Welch Drug Development; Drug Regulatory Process; Drug Safety Yes 0.5 FDA’s Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond Drug Regulatory Process No 0 FDA’s Work to Combat the COVID-19 Pandemic COVID-19; Drug Development; Drug Regulatory Process; Drug Safety No 0 Fraudulent Products – Hidden Ingredients and Unproven Claims in Products Marketed as Dietary Supplements Drug Regulatory Process; Drug Safety Yes 1 Frequently Asked Questions about Labeling for Prescription Medicines Drug Regulatory Process; Drug Development; Drug Safety Yes 1 GDUFA II Videos and Resources Drug Development; Generic Drugs No 0 Generics and Biosimilars Biosimilars; Drug Regulatory Process; Drug Development; Generic Drugs No 0 Generics-at-a-Glance with Dr. Sarah Ibrahim Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs Yes 0.5 Health Equity Forum Podcast COVID-19; Drug Development; Drug Regulatory Process; Drug Safety; Women’s Health No 0 Health Fraud Product Database Drug Safety; Health Fraud No 0 Health Fraud Scams Drug Safety: Health Fraud No 0 How FDA and ISMP Utilize Medication Error Reports to Improve Drug Safety Drug Regulatory Process; Drug Safety Yes 1 How to Avoid Medication Errors with Pen Injectors Drug Safety; MedWatch Yes 1 How to Use the Consumer Complaint System and MedWatch Drug Safety; MedWatch No 0 Hyperemesis Gravidarum: New Research and Insights Women’s Health; Drug Safety Yes 1 Incorporating Biosimilars Into the Management of Patients With Immunological Conditions Biosimilars; Cancer Drugs; Case Study; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch; Women’s Health Yes 1 Increasing the Efficiency of Biosimilar Development Programs Biosimilars;Drug Regulatory Process; Drug Development No 0 Increasing the Efficiency of Biosimilar Development Programs 2023 Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety No 0 Information about Medications for Opioid Use Disorder (MOUD) Drug Regulatory Process; Drug Safety; Opioids No 0 Insanitary Conditions and Sterility Assurance Compounding; Drug Development; Drug Regulatory Process; Drug Safety Yes 4 Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0 Interchangeable Biological Products Biosimilars No 0 Interchangeable Biosimilars Biosimilars No 0 Investigations and Corrective and Preventive Actions (CAPA) 2023 Compounding; Drug Development; Drug Regulatory Process; Drug Safety Yes 5 Investigations and Corrective and Preventive Actions (CAPA) Virtual Course 2024 Compounding; Drug Regulatory Process; Drug Development No 0 Joint US FDA – Health Canada ICH Public Meeting Drug Development; Drug Regulatory Process; Drug Safety; IND/Expanded Access No 0 Leveraging Health Literacy and Patient Preferences to Reduce Hypoglycemia Events in Patients with Type 2 Diabetes Drug Safety No 0 Maximizing Benefits and Minimizing Harms from Antibiotics Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch No 0 Medical Extended Reality: Applications and Challenges Drug Regulatory Process; Drug Development; Drug Safety No 0 Medication Health Fraud and Avoiding Medication Scams with Cynthia Ng Drug Safety; MedWatch; Generic Drugs; Drug Regulatory Process Yes 0.5 MedWatch, Your Report Can Make a Difference with Dr. Gerald Dal Pan Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch Yes 0.5 Minority Health and Health Equity Webinars Drug Development; Drug Regulatory Process; Drug Safety, Minority Health No 0 Naltrexone Injection for Opioid Use Disorder – FDA’s Efforts to Reduce Medication Errors Drug Regulatory Process; Drug Safety; MedWatch; Opioids No 0 Navigating the World of Online Pharmacies with CDR Lysette Deshields Drug Regulatory Process; Drug Safety; Health Fraud Yes 0.5 OMHHE Health Equity Forum Podcast – Toward Improving Race and Ethnicity Data in Healthcare Drug Development; Drug Regulatory Process No 0 Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0 Opioid and Nicotine Use, Dependence, and Recovery: Influences of Sex and Gender Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; MedWatch; Opioids; Women’s Health No 0 Outsourcing Facility Guide Compounding; Drug Development; Drug Regulatory Process; Drug Safety Yes 1.75 Overcoming Reluctance and Enhancing Biosimilar Adoption Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety No 0 Overcoming Reluctance and Enhancing Biosimilar Adoption (Medscape) Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety Yes 0.5 Overview of Expanded Access (EA) Program and EA eRequest Site IND/Expanded Access; Rare Diseases; Drug Regulatory Process; Drug Development; Drug Safety Yes 1 Overview of FDA role regulating and approving drugs Drug Development; Drug Regulatory Process; Drug Safety; MedWatch No 0 An Overview of FDA’s Project Facilitate Oncology Expanded Access Program Cancer Drugs; Disease States; Drug Development; Drug Regulatory Process Yes 1 PCOS Revisited: Diagnosis, Management, and Future Needs  Women’s Health; Drug Safety Yes 1 Personnel Gowning in Sterile Drug Production Compounding; Drug Development; Drug Regulatory Process; Drug Safety Yes 0.5 Pregnancy and Lactation Medication Information for the Healthcare Provider Women’s Health; Drug Regulatory Process; Drug Safety Yes 1 Prescribe with Confidence Drug Regulatory Process; Drug Safety; Opioids No 0 Primary Care Providers Can Prescribe with Confidence Drug Regulatory Process; Drug Safety; Opioids No 0 Process Validation Virtual Course Compounding; Drug Regulatory Process; Drug Development Yes 15 Public meeting: FDA Rare Disease Day 2024 Drug Regulatory Process; Drug Safety Rare Diseases Yes 4.75 Putting the Patient into Perspective: Strategies for Educating Patients about Biosimilars Biosimilars; Cancer Drugs; Case Study; Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; MedWatch; Women’s Health Yes 0.25 Q&A with FDA Podcast COVID-19; Drug Regulatory Process; Drug Development; Drug Safety; MedWatch Yes 0.5 Quality Management Systems Virtual Course Compounding; Drug Regulatory Process; Drug Development Yes 15 Rare Diseases – Challenges and Progress in Drug Development Drug Development; Drug Safety; Rare Diseases Yes 1 READDI for the next pandemic Drug Development; Drug Regulatory Process; Drug Safety No 0 Regulatory Framework for Human Drug Compounding Compounding; Drug Development; Drug Regulatory Process; Drug Safety Yes 1.5 Regulatory Science at CDER Videos Drug Regulatory Process; Drug Development No 0 Reporting and Public Viewing of Individual Case Safety Reports (ICSRs) Drug Regulatory Process; Drug Development; Drug Safety; MedWatch Yes 1 Reporting Unlawful Sales of Medical Products on the Internet Drug Safety No 0 Risk Evaluation and Mitigation Strategies (REMS) Program Part 1 Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0 Risk Evaluation and Mitigation Strategies (REMS) Program Part 2 Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs No 0 Safe Opioid Disposal Drug Regulatory Process; Drug Development; Drug Safety; MedWatch; Generic Drugs; Cancer Drugs;Opioids No 0 Safety Labeling Changes for Leukotriene Receptor Antagonists and Decisions Behind a Boxed Warning Drug Regulatory Process; Drug Development; Drug Safety; MedWatch Yes 1 Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs No 0 SBIA Chronicles Drug Regulatory Process No 0 Second Annual FDA ASCO WORKSHOP on Getting the Dosage Right Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0 Stability and Beyond Use Dates Case Study; Compounding; Drug Development; Drug Regulatory Process; Drug Safety; MedWatch; Case Study Yes 4 State of Outsourcing Facility Sector and Possibilities for the Future Compounding; Drug Development; Drug Regulatory Process; Drug Safety No 0 A Step Forward in the Treatment of Opioid and Alcohol Dependence with Dr. Iilun Murphy and Dr. Marta Sokolowska Drug Regulatory Process; Drug Safety; Generic Drugs; Opioids Yes 0.5 Sterile Drug Compounding In-person Course Compounding; Drug Regulatory Process; Drug Development Yes 16 Sterility Testing: Common Misconceptions Compounding; Drug Development; Drug Regulatory Process; Drug Safety Yes 0.75 Successes and Opportunities in Modeling and Simulation for FDA Drug Development; Drug Regulatory Process No 0 Summary Report for Biosimilars Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety No 0 Supplier/Contractor Qualification and Management Compounding; Drug Development; Drug Regulatory Process; Drug Safety Yes 4 Switching Between Biosimilars and Their Reference Counterparts with Dr. Sarah Yim Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety Yes 0.5 The Current Status of Oral Phenylephrine as a Nasal Decongestant with Dr. Theresa Michele and Dr. Ilisa Bernstein Drug Regulatory Process; Drug Safety; OTC Drug Regulations Yes 0.5 The FDA Bad Ad Program and Prescription Drug Promotion Drug Regulatory Process; Drug Safety No 0 The FDA Process for Approving Generic Drugs Drug Regulatory Process; Drug Development; Generic Drugs No 0 The Future of Clinical Trials, The Real Cost Campaign, and Sun Safety Tips Drug Development; Drug Regulatory Process; Drug Safety; Suncreen No 0 The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development Biosimilars; Drug Development; Drug Regulatory Process; Drug Safety No 0 The Safety Evaluation and Surveillance of Generic Drugs Generic Drugs; Drug Regulatory Process; Drug Development; Drug Safety Yes 1.5 Topics in Public Health Biosimilars; Cancer Drugs; Case Study; Compounding; COVID-19; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; IND/Expanded Access; MedWatch; Opioids; OTC Drug Regulations; Women’s Health Yes 1 Treatment Using Medication for Opioid Use Disorder Can Save Lives Drug Regulatory Process; Drug Safety; Opioids No 0 Understanding Generic Narrow Therapeutic Index Drugs Generic Drugs; Drug Regulatory Process; Drug Development; Drug Safety Yes 1 Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity Drug Regulatory Process; Drug Development; Drug Safety Yes 0.5 Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity Drug Development; Drug Regulatory Process; Drug Safety; MedWatch No 0 Using Bayesian Statistical Approaches to Advance our Ability to Evaluate Drug Products Drug Development; Drug Regulatory Process; Drug Safety No 0 What does FDA regulate? Drug Regulatory Process; Drug Development; Drug Safety; Generic Drugs; OTC Drug Regulations; Women’s Health No 0 What is a Biosimilar? Biosimilars; Drug Regulatory Process; Drug Development No 0 What is a Biosimilar? (Spanish) Biosimilars; Drug Regulatory Process; Drug Development; Español No 0 Where and How to Dispose of Unused Medicines Drug Safety; Opioids No 0 Why Does the FDA Exist? Drug Development; Drug Regulatory Process; Drug Safety No 0 FDA Drug Topics Webinars Biosimilars; Cancer Drugs; Cannabidiol; Compounding; Drug Development; Drug Regulatory Process; Drug Safety; Generic Drugs; Health Fraud; IND/Expanded Access; Opioids; Rare Diseases Yes 1 FDA approvals of Augtyro (repotrectinib) and Krazati (adagrasib) Cancer Drugs; Drug Development; Drug Regulatory Process; Drug Safety No 0 Real-World Data and Evidence Generation with Dr. Hilary Marston Drug Development; Drug Regulatory Process; Drug Safety; Artificial Intelligence No 0 Medicamentos biosimilares: Lo que los pacientes deben saber Biosimilars; Drug Regulatory Process; Drug Development; Drug Safety No 0 What is Accelerated Approval? Cancer Drugs; Drug Regulatory Process; Drug Development; Drug Safety No 0 How are Cancer Drugs Approved? Cancer Drugs; Drug Regulatory Process; Drug Development; Drug Safety No 0

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