CDER Manual of Policies & Procedures

5015.14 Office of Pharmaceutical Quality Prioritization of Solicited DMF Amendments Associated With ANDAs or PASs not Concurrently Under Assessment Regulatory Review and Scientific Policies 5/7/2024 7610.1 Office of Strategic Programs CDER Records Management Information Technology 3/22/2024 6702.3 Office of Surveillance and Epidemiology Review of Proposed Methodological Approaches to Assess a Risk Evaluation and Mitigation Strategy (REMS)  Drug Safety 3/25/2024 6702.1 Office of Surveillance and Epidemiology Review of Risk Evaluation and Mitigation Strategy (REMS) Assessment Reports Drug Safety 3/25/2024 5017.8 Office of Pharmaceutical Quality Responsibilities for the Assessment of In Vitro Testing for Oral Drug Products Administered Via Enteral Feeding Tube Regulatory Review and Scientific Policies 8/31/2023 5016.8 Rev. 1 Office of Pharmaceutical Quality Using Four-Part Harmony in Quality-Related Assessment Communications Regulatory Review and Scientific Policies 8/25/2023 4301.1 Rev. 3 Office of Medical Policy CDER Medical Policy Council Leadership and Mission 2/23/2021 5021.5 Rev. 1 Office of Pharmaceutical Quality Assessment of Facility-Based Deficiency Major-to-Minor Reclassification Requests Regulatory Review and Scientific Policies 12/21/2023 6021.1 Office of New Drugs NDAs/BLAs: Financial Disclosure New Drug Review 6/21/2017 4100.2 Office of Translational Sciences

CDER Staff Participation in Public Private Partnerships and Consortia

Regulatory Review and Scientific Policies 4/21/2023 5100.3 Office of Clinical Pharmacology OCP Prioritization, Triage, and Review Process for INDs and Pre-INDs Regulatory Review and Scientific Policies 3/30/2023 4651.3 Office of Management PHS Commissioned Corps Awards Staff Resources and Services 2/27/2023 5015.13 Office of Pharmaceutical Quality Quality Assessment for Products in Expedited Programs Regulatory Review and Scientific Policies  11/1/2022 5022.0 Office of Pharmaceutical Quality Roles and Responsibilities of FDA Liaisons to Standards Development Organizations Regulatory Review and Scientific Policies 12/7/2022 5015.12  Office of Pharmaceutical Quality Process for Evaluating Emerging Technologies Related to Quality Regulatory Review and Scientific Policies  11/29/2022 5100.6 Office of Translational Science Policy and Procedures for Creating an Interest Group in the Office of Biostatistics Regulatory Review and Innovation  6/23/2022 5019.2  Office of Pharmaceutical Quality Assessment of the Appropriate Net Container Content for Injectable Drug and Biological Products Regulatory Review and Scientific Policies 6/13/2022 5223.6 Office of Generic Drugs Assessment of the User Interface of a Drug-Device Combination Product Submitted in a Pre-ANDA Communication or an ANDA Generic Drug Review 6/7/2022 5220.3 Office of Generic Drugs Communicating Certain Deficiencies Identified During Filing Review of ANDAs Generic Drug Review 9/28/2017 5240.10 Office of Generic Drugs Classifying Approved New Drug Products and Drug-device Combination Products as Complex Products for Generic Drug Development Purposes Generic Drug Review 4/13/2022 4151.8 Rev. 1 Office of Executive Program Equal Voice: Collaboration and Regulatory and Policy Decision-Making in CDER Staff Resources & Services 4/12/2022 5019.1 Rev.1 Office of Pharmaceutical Quality Allowable Excess Volume/Content in Injectable Drug and Biological Products Regulatory Review and Scientific Policies 1/29/2022 6050.2 Rev. 1 Office of Management Effect of Failure to Pay BsUFA Fees Staff Resources and Services 10/05/2023 5021.1 Rev.1 Office of Pharmaceutical Quality Naming of Drug Products Containing Salt Drug Substances Regulatory Review and Scientific Policies 12/2/2022 5021.2 Office of Pharmaceutical Quality Evaluating Color Additives and Flavors Intended for Oral Drug Products Submitted or Referenced in INDs and NDAs Regulatory Review and Scientific Policies 6/3/2021 4657.0 Rev. 1 Office of Management CDER’s Time, Attendance, and Leave Recording Policy Staff Resources and Services 5/19/2021 7600.10 Office of Strategic Programs CDER Master Data Management Information Technology 4/15/2022 7610.8 Office of Strategic Programs Electronic and Digital Signatures for Records Management Drug 8/12/2022 6720.4 Office of Surveillance and Epidemiology Procedures for Sharing Non-public Information on Pending Proposed Proprietary Names Drug Safety 9/21/2016 6030.3 Office of New Drugs Emergency Investigational New Drug Application Process During and After Normal Business Hours New Drug Review 9/5/2018 5241.3 Rev.1 Office of Generic Drugs and Office of Pharmaceutical Quality Good Abbreviated New Drug Application Assessment Practices Generic Drug Review 10/6/2023 5240.3 Rev.6 Office of Generic Drugs Prioritization of the Review of Original ANDAs, Amendments, and Supplements Generic Drug Review 12/14/2022 5231.1 Office of Compliance CDER Barcode Inquiries Public Outreach 11/15/2018 5220.5 Rev.2 Office of Generic Drugs Issuance of Information Requests and/or Discipline Review Letters for ANDAs under the Reauthorization of GDUFA Generic Drug Review 10/5/2022 5220.1 Office of Generic Drugs Receiving and Processing a Request for Voluntary Withdrawal of an Approved ANDA Generic Drug Review 1/25/2023 5200.14 Rev.1 Office of Generic Drugs Filing Review of Abbreviated New Drug Applications Generic Drug Review 10/2/2023 5200.12 Office of Generic Drugs and Office of Pharmaceutical Quality Communicating Abbreviated New Drug Application Review Status Updates with Industry Generic Drug Review and Regulatory Review and Scientific Policies 10/5/2022 5200.7 Rev.1 Office of Generic Drugs ANDA Amendments and Supplements Reviewed by the Division of Filing Review Generic Drug Review 4/17/2020 5016.6 Office of Pharmaceutical Quality Change in Hard Gelatin Capsule Supplier Regulatory Review and Scientific Policies 2/21/2023 5014.1 Rev.1 Office of Pharmaceutical Quality Understanding CDER’s Risk-Based Site Selection Model Regulatory Review and Scientific Policies 6/26/2023 5001.1 Office of Pharmaceutical Quality Drug Product Distribution After a Complete Response Action to a Changes Being Effected Supplement Regulatory Review and Scientific Policies 11/23/2022 4410.1 Rev. 1. Office of Communications FDA Pharmacy Student Experiential Program Public Outreach 8/28/2019 5242.1 Office of Generic Drugs Transfer of Ownership Generic Drug Review 8/26/2020 6701.4 Office of Surveillance and Epidemiology Notifying Applicants of Sentinel Analyses and Results Drug Review 8/17/2020 6702.2 Office of Surveillance and Epidemiology Determination of the Need for and Review of a New REMS Drug Review 6/18/2020 5220.2 Office of Generic Drugs Conversion of ANDA Approval to Tentative Approval Because of Court Order Generic Drug Review 6/11/2020 4121.3 Office of the Center Director Collaborative Identification, Evaluation, and Resolution of a Newly Identified Safety Signal (NISS) Leadership and Mission 4/30/2020 6701.1 Office of Surveillance and Epidemiology Procedures for DMEPA Intra-Center Consult to DMPP on Patient-Oriented Labeling Submitted with Human Factors Validation Study Protocols Drug Safety 9/18/2019 5220.8 Office of Generic Drugs Evaluating Requests for and Conducting Product Development and Pre-Submission Pre-ANDA Meetings Generic Drug Review 10/5/2022 4191.1 Office of New Drugs Risk Evaluation and Mitigation Strategies Modifications and Revisions New Drug Review 6/29/2020 6004.3 Office of New Drugs Safety Labeling Changes Under Section 505(o)(4) of the FD&C Act New Drug Review 7/09/2019 6720.5 Office of Surveillance and Epidemiology Procedures for Handling Requests for Nonproprietary Name Suffix Review for Biological Products Newly Licensed Under Section 351of the PHS Act Drug Safety 3/7/2019 6701.3 Rev.1 Office of Surveillance and Epidemiology Development of a Single, Shared System (SSS) Risk Evaluation and Mitigation Strategy (REMS) or a Separate REMS with Elements to Assure Safe Use (ETASU): Responsibilities and Procedures Drug Safety 10/28/2020 4000.1 Rev.6 Office of Management Developing and Issuing MAPPs for CDER Staff Resources and Services 9/9/2021 4000.4 Rev 1 Office of Translational Sciences Clinical Pharmacology and Biopharmaceutics NDA Review Template Regulatory Review and Innovation 1/30/2023 4112.2 Rev.1 Office of Executive Programs Sharing Nonpublic Information with Federal Government Officials. Regulatory Policy and Information Disclosure 10/27/2022 4160.2 Rev.1 Office of the Center Director Prioritization of Requests for Training and Visits by Foreign Regulatory Agencies and International Regulatory Organizations Leadership and Mission 11/9/2022 7400.13 Office of New Drugs Determining the Established Pharmacologic Class for Use in the Highlights of Prescribing Information New Drug Review 7/25/2018 4200.1 Rev.1 Office of the Center Director Procedures for Review of Protocols Referred By DEA That use Schedule I controlled Substances and Drugs Leadership and Mission 11/12/2020 4200.2 Rev.2 Office of the Center Director Forecasting Schedule I and II Substance and Drug Needs Leadership and Mission 5/8/2024 4200.3 Rev.2 Office of the Center Director Consulting the Controlled Substance Staff on Abuse Liability, Drug Dependence, Risk Management, and Drug Scheduling Drug Safety 10/26/2022 4601.3 Rev.2 Office of Management Children in the Workplace Staff Resources and Services 1/22/2021 4516.1 Rev. 1 Office of Communications Criteria for Developing and Publishing Digital Content on the CDER External Web Site Public Outreach 3/12/2020 4512.2 Rev.2 Office of Strategic Programs Conducting Effective Meetings in CDER: Remote Access Considerations Information Technology 12/8/2021 4510.2 Rev.2 Office of Regulatory Policy CDER Clearance of FDA Related Articles,Speeches and Other Publications Regulatory Policy and Information Disclosure 9/17/2020 4510.1 Rev.2 Office of Communications CDER Process for Authorizing Staff to Participate in External Events Public Outreach 11/25/2022 4520.1 Rev. 2 Office of Communications Communicating Drug Approval Information Public Outreach 11/10/2022 5017.1Rev.1 Office of Pharmaceutical Quality Office of Biotechnology Products and Office of Pharmaceutical Manufacturing Assessment, Interactions on BLA Assessments  Regulatory Review and Scientific Policies 12/2/2022 5015.7 Rev.1 Office of Pharmaceutical Quality Environmental Assessments Regulatory Review and Scientific Policies 11/23/2022 5015.6 Rev.1 Office of Pharmaceutical Quality Review of Grouped Product Quality Supplements  Regulatory Review and Scientific Policies 12/9/2022 5015.5 Rev.1 Office of Pharmaceutical Quality CMC Reviews of Type III DMF’s for Packaging Materials Regulatory Review and Scientific Policies 12/9/2022 5015.8 Office of Pharmaceutical Quality Acceptance Criteria for Residual Solvents Regulatory Review and Scientific Policies 12/1/2022 5016.1 Office of Pharmaceutical Quality Applying ICH Q8(R2), Q9, and Q10 Principles to CMC Review Regulatory Review and Scientific Policies 1/21/2022 5040.1 Office of Pharmaceutical Quality Product Quality Microbiology Information in the Common Technical Document – Quality (CTD-Q) Regulatory Review and Scientific Policies 12/7/2022 5100.4 Rev.1 Office of Translational Sciences Scientific Interest Groups: Criteria and Policies. Regulatory Review and Innovation 9/1/2021 5210.4 Rev 3 Office of Generic Drugs Assessment of Bioequivalence Studies with Clinical Endpoints in ANDAs Generic Drug Review 4/28/2023 5210.5 Rev.3 Office of Generic Drugs Review of Investigational New Drug Applications (Bio-INDs) by the Office of Generic Drugs Generic Drug Review 4/14/2022 5230.3 Rev.2 Office of Generic Drugs Generic Drug Labeling Revisions Covered Under Section 505(j)(10) of the Federal Food, Drug, and Cosmetic Act Generic Drug Review 12/13/2023 6020.4 Rev.2 Office of New Drugs Classifying Resubmissions of Original NDAs, BLAs, and Efficiacy Supplements in Response to Action Letters New Drug Review 2/26/2015 6020.2 Rev.1 Office of New Drugs Applications for Parenteral Products in Plastic Immediate Containers New Drug Review 12/19/2023 6010.9 Office of New Drugs Procedures and Responsibilities for Developing Postmarketing Requirements and Commitments New Drug Review 3/9/2009 6010.8 Rev.1 Office of New Drugs NDAs and BLAs: Communication to Applicants of Planned Review Timelines New Drug Review 8/25/2014 6010.5 Office of New Drugs NDAs: Filing Review Issues New Drug Review 3/27/2018 6010.2 Office of New Drugs Responsibilities for Tracking and Communicating the Status of Postmarketing Requirements and Commitments New Drug Review 7/28/2009 5210.9 Rev.1 Office of Pharmaceutical Quality Review of Botanical Drug Products Regulatory Review and Scientific Policies 1/21/2022 6004.2 Rev.2 Office of New Drugs Procedures for Completing and Processing the Form “Annual Status Report Review Form: PMR and PMC Summary” New Drug Review 9/27/2017 4190.1 Rev.4 Office of the Center Director

Drug Shortage Management

Medical Policy 2/1/2024 6001.1 Rev. 1 Office of Executive Programs Special Government Employees Representing Sponsors Before CDER Executive Secretariat 9/16/2022 5310.7 Rev.1 Office of Pharmaceutical Quality Acceptability of Standards From Alternative Compendia (BP/EP/JP) Regulatory Review and Scientific Policies 9/18/2024 5310.3 Rev.2 Office of Pharmaceutical Quality Requests for Expedited Review of New Drug Application and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and Controls Changes Regulatory Review and Scientific Policies 4/08/2021 6030.1 Rev.3 Office of New Drugs IND Clinical Holds New Drug Review 2/20/2018 6020.8 Rev 1 Office of New Drugs NDAs/BLAs/Efficacy Supplements: Action Packages and Taking Regulatory Actions New Drug Review 6/14/2016 6020.5 Rev. 2 Office of New Drugs Good Review Practice: OND Review Management of INDs and NDAs for Nonprescription Drug Products New Drug Review 6/25/2018 7600.6 Rev. 2 Office of Strategic Programs Requesting and Accepting Non-Archivable Records in Electronic Format for New Drug Applications Information Technology 4/24/2023 7500.1 Rev. 2 Office of New Drugs Regulatory Project Management Coordinating Committee New Drug Review 9/5/2018 7400.1 Rev.2 Office of New Drugs Management of CDER Pharmacology/Toxicology Coordinating Committee and Its Associated Subcommittees and Working Groups New Drug Review 5/17/2016 6720.2 Rev.2 Office of Surveillance and Epidemiology Procedures for Handling Requests for Proprietary Name Review Drug Safety 8/8/2024 6700.5 Office of Surveillance and Epidemiology Responding to Requests For Waivers of Postmarketing Safety Reporting Requirements under 21 CFR §§ 314.80 (NDAs), 314.98 (ANDAs), and 600.80 (BLAs) Drug Safety 7/25/2022 6700.9 Office of Surveillance and Epidemiology 6700.9 (PDF – 121KB) FDA Posting of Potential Signals of Serious Risks Identified by the Adverse Event Reporting System Drug Safety 9/10/2019 6610.1 Rev. 2 Office of Translational Sciences and Biostatistics Statistical Policy Council Regulatory Review and Innovation 6/1/2021 6050.1 Rev. 2 Office of Management Effect of Failure to Pay PDUFA Fees Staff Resources and Services 12/01/2021 6030.9 Office of New Drugs Good Review Practice: Good Review Management Principles and Practices for Effective IND Development and Review New Drug Review 4/29/2013 6030.8 Rev.1 Office of New Drugs INDs: Exception from Informed Consent Requirements for Emergency Research New Drug Review 11/17/2014 6030.6 Office of New Drugs INDs: Processing Treatment INDs and Treatment Protocols New Drug Review 12/9/2011 6030.2 Rev.1 Office of New Drugs INDs: Review of Informed Consent Documents New Drug Review 5/2/2014 6020.3 Rev.2 Office of New Drugs Review Designation Policy: Priority (P) and Standard (S) New Drug Review 6/25/2013 5240.5 Rev.3 Office of Generic Drugs ANDA Suitability Petitions Generic Drug Review 9/29/2023 7620.6 Rev.1 Office of the Center Director Procedure for Review and Clearance of ICH Guidelines Information Technology 3/19/2024 7610.6 Rev.1 Office of Strategic Programs CDER Electronic Application Forms Oversight Information Technology 10/7/2022 6025.4 Office of New Drugs Good Review Practice: Refuse to File New Drug Review 9/5/2018 6025.2 Office of New Drugs Good Review Practice: Clinical Review of Investigational New Drug Applications New Drug Review 3/5/2018 7412.1 Rev.2 Office of New Drugs Management of CDER Executive Carcinogenicity Assessment Committee and Communication of Committee Proceedings New Drug Review 6/8/2018 7412.2 Rev.1 Office of New Drugs Management of CDER Carcinogenicity Assessment Committee and Communication of Committee Proceedings New Drug Review 6/7/2018 4642.3 Office of Management Student Volunteer Employment Program (SVEP) Staff Resources and Services 10/5/2023 6025.6 Rev.1 Office of New Drugs Good Review Practice: Management of Breakthrough Therapy-Designated Drugs and Biologics New Drug Review 2/28/2024 5016.3
Rev. 1 Office of Pharmaceutical Quality Responsibility for the Quality Assessment of Products Containing Peptide or Protein Drug Substances Regulatory Review and Scientific Policies 6/21/2023 7600.11 Office of Strategic Programs CDER Electronic Record Keeping System Information Technology 9/29/2014 4100.1 Rev.2 Office of Management CDER Co-Sponsorship Agreements for Events Staff Resources and Services 6/21/2022 7700.5 Rev.1 Office of Translational Sciences Critical Path Innovation Meetings Policy and Procedures Regulatory Review and Innovation 4/14/2021 4001.1 Office of Management Developing, Issuing and Maintaining Standard Operating Procedures for CDER Staff Resources and Services 2/1/2023 6025.7 Rev.1 Office of New Drugs Good Review Practice: Review of Marketing Applications for Breakthrough Therapy-Designated Drugs and Biologics That Are Receiving an Expedited Review New Drug Review  2/28/2024 4651.4 Rev.1 Office of Management CDER Incentive Awards Program (Cash and Time-off) Staff Resources and Services 7/16/2020 4800.2 Rev.1 Office of the Center Director Continuity of Operations (COOP) Leadership and Mission 7/21/2021 7610.7 Rev.1 Office of Strategic Programs CDER Data Standards Program Information Technology 8/31/2021 5241.2 Rev. 1 Office of Generic Drugs Consolidation of ANDAs by the Office of Generic Drugs Generic Drug Review 8/19/2020 6001.2 Rev.2 Office of Communications CDER Network Of Experts Leadership and Mission 2/1/2024 5018.2 Office of Pharmaceutical Quality NDA Classification Codes Regulatory Review and Scientific Policies 12/6/2022

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