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  1. Center for Drug Evaluation and Research | CDER

CDER Manual of Policies & Procedures | MAPP

CDER's Manual of Policies and Procedures (MAPPs) are federal directives and documentation of internal policies and procedures. MAPPs are required by law, and made available to the public to make CDER a more transparent organization.  For more information about MAPPs, please contact the CDER MAPP Team: CDERMAPPTEAM@fda.hhs.gov 

This page contains the current CDER Manual of Policies and Procedures (MAPPs) in Adobe Acrobat Format (PDF). 

Regulatory Review and Scientific Policies
MAPP # Office Title Category Date Posted
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 9/19/2019
4191.1 Office of New Drugs Risk Evaluation and Mitigation Strategies Modifications and Revisions New Drug Review 7/10/2019
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
5017.4 Office of Pharmaceutical Quality Quality Center for Drug Evaluation and Research Biopharmaceutics Council Regulatory Review and Scientific Policies 4/24/2019
6720.5.3 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 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 2/7/2019
4000.2 Office of Regulatory Policy Developing and Issuing Guidance Regulatory Policy and Information Disclosure 10/3/2005
4000.1 Rev.5 Office of Management Developing and Issuing MAPPs for CDER Staff Resources and Services 8/23/2017
4000.3 Office of Regulatory Policy Submitting Proposals to the Office of Regulatory Policy (ORP) for Early Analysis of Rulemaking Initiatives Regulatory Policy and Information Disclosure 10/23/2001
4000.4 Rev 1 Office of Translational Sciences Clinical Pharmacology and Biopharmaceutics NDA Review Template Regulatory Review and Innovation 9/22/2016
4000.10 Rev.1 Office of New Drugs Developing Indication-Specific Guidances New Drug Review 11/21/2014
4151.7 Office of the Center Director Joint Safety Meetings Between OND and OSE Leadership and Mission 3/26/2009
4151.3 R4 Office of the Center Director Drug Safety Oversight Board (DSB) Leadership and Mission 9/13/2016
4151.4 Office of Translational Sciences Multi-Disciplinary Procedures for Managing End-Of-Phase 2A Meeting Regulatory Review and Innovation 5/4/2010
4151.2Rev.1 Office of the Center Director Resolution of Differing Professional Opinions: Review by Ad Hoc Panel and CDER Director Leadership and Mission 10/12/2010
4151.1Rev.1 Office of the Center Director Scientific / Regulatory Dispute Resolution for Individuals Within a Management Chain Leadership and Mission 10/12/2010
4150.1 Office of Executive Programs Role and Procedures of the CDER Ombudsman Executive Secretariat 10/18/2002
4140.6 Office of Regulatory Policy Editing Procedures Regulatory Policy and Information Disclosure 12/11/2002
4140.5 Office of Regulatory Policy Submitting Issues/Documents to the Office of the Chief Counsel (OCC) for Legal Review, Comment, or Clearance Regulatory Policy and Information Disclosure 3/22/2002
4121.2 Office of the Center Director Tracking of Significant Safety Issues in Marketed Drugs -- Use of the DARRTS Tracked Safety Issue Leadership and Mission 1/4/2012
4112.2 Office of Executive Programs Sharing Nonpublic Information with Federal Government Officials. Regulatory Policy and Information Disclosure 7/12/2002
4151.8 Office of the Center Director Equal Voice: Discipline and Organizational Component Collaboration in Scientific and/or Regulatory Decisions Leadership and Mission 10/12/2010
4151.15 Office of the Center Director Collaboration in Managing the CDER Drug Quality Oversight Program Leadership and Mission 2/1/2013
4160.2 Office of Stategic Programs Prioritization of Requests for Training and Visits by Foreign Regulatory Agencies and International Regulatory Organizations Information Technology 5/31/2000
4180.4 Office of New Drugs NDAs/BLAs: Using the 21st Century Review Process Desk Reference Guide New Drug Review 3/17/2015
4180.3 Office of Translational Sciences Processing and Reviewing Voluntary Genomic Data Submissions (VGDSs) Regulatory Review and Innovation 3/22/2005
4180.2 Office of Translational Sciences Management of the Interdisciplinary Pharmacogenomics Review Group (IPRG) Regulatory Review and Innovation 3/22/2005
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 Office of the Center Director Consulting the Controlled Substance Staff on INDs and ProtocolsThat Use Schedule I Controlled Substances and Drugs Leadership and Mission 5/14/2003
4200.2 Office of the Center Director Forecasting Schedule I and II Substance and Drug Needs Leadership and Mission 5/14/2003
4200.3 Rev.1 Office of the Center Director Consulting the Controlled Substance Staff on Abuse Liability, Drug Dependence, Risk Management, and Drug Scheduling Drug Safety 3/6/2017
4200.4 Office of the Center Director Office of Generic Drugs (OGD) Consultation with the Controlled Substance Staff (CSS) on Subject Abbreviated New Drug Application (ANDA) Submissions Leadership and Mission 2/9/2011
4301.1Rev.2 Office of Medical Policy Center for Drug Evaluation and Research Medical Policy Council Medical Policy 9/6/2017
4400.1 Office of Executive Programs Guide to the Orientation Program in the Center for Drug Evaluation and Research Executive Secretariat 7/18/2011
4400.3 Office of Executive Programs CDER Federated Training Model Executive Secretariat 7/18/2011
4655.3 Rev 4 Office of Management Procedures for CDER Medical Officer Conversion to Career-Conditional Staff Resources and Services 9/27/2018
4652.1 Office of Management Property Management Program Staff Resources and Services 3/29/2012
4643.8 Office of Management Relocation Program Staff Resources and Services 1/18/2017
4642.1 Office of Management Policies and Procedures for Organizational Changes Staff Resources and Services 5/4/2007
4641.8 Rev.1 Office of Management Reimbursement for Professional Liability Insurance Staff Resources and Services 3/14/2014
4641.3 Office of Management Outside Activities Staff Resources and Services 8/8/2008
4631.2 Office of Management Preparation of Purchase/Service/Stock Requisitions in iProcurement Staff Resources and Services 6/20/2013
4631.1 Rev.1 Office of Management Supplement to Authority to Make Allotments and Authorize the Establishment of Allowances Staff Resources and Services 6/20/2013
4602.1 Office of Management Telephone Coverage and Responsiveness Staff Resources and Services 3/28/2012
4601.3 Rev.1 Office of Management Children in the Workplace Staff Resources and Services 4/13/2015
4516.1 Office of Communications Criteria for Developing and Publishing Digital Content on the CDER External Web Site Public Outreach 12/28/2012
4515.1 Office of Communications Email best practices Public Outreach 5/21/2013
4512.2 Rev.1 Office of Communications Conducting Effective Meetings in CDER: Remote Access Considerations Public Outreach 5/20/2015
4510.2 Rev.2 Office of Communications Clearance of Speeches, Articles and Other Communication Materials Public Outreach 10/22/2013
4510.1 Rev.1 Office of Communications CDER Authorization and Tracking of Outside Speaker Clearance Public Outreach 4/10/2013
4520.1 Rev. 2 Office of Communications Communicating Drug Approval Information Public Outreach 7/17/2017
5017.1Rev.1 Office of Pharmaceutical Quality Office of Biotechnology Products and Office of Compliance Division of Manufacturing  Regulatory Review and Scientific Policies 7/26/2017
4658.3 Rev.3 Office of Management Requesting New Full -Time Equivalents Staff Resources and Services 12/8/2015
4657.9 Rev.4 Office of Management Restoration of Forfeited Annual Leave Staff Resources and Services 7/9/2014
4657 Office of Management CDER's Time, Attendance, and Leave Recording Policy Staff Resources and Services 5/4/2007
5015.7 Rev.1 Office of Pharmaceutical Quality Environmental Assessments Regulatory Review and Scientific Policies 9/14/2017
5015.6 Rev.1 Office of Pharmaceutical Quality Review of the Same Supplemental Change to More than One NDA or ANDA in More Than One Review Division Regulatory Review and Scientific Policies 4/19/2016
5015.5 Rev.1 Office of Pharmaceutical Quality CMC Reviews of Type III DMF's for Packaging Materials Regulatory Review and Scientific Policies 10/18/2017
5015.8 Office of Pharmaceutical Quality Acceptance Criteria for Residual Solvents_MAPP Regulatory Review and Scientific Policies 6/28/2017
5016.1 Office of Pharmaceutical Quality Applying ICH Q8(R2), Q9, and Q10 Principles to CMC Review Regulatory Review and Scientific Policies 5/17/2016
5040.1 Office of Pharmaceutical Quality Product Quality Microbiology Information in the Common Technical Document - Quality (CTD-Q) Regulatory Review and Scientific Policies 1/25/2017
5100.3 Office of Translational Sciences OCP Prioritization, Triage, and Review Process for INDs and Pre-INDs Regulatory Review and Innovation 5/30/2006
5100.4 Office of Translational Sciences Scientific Interest Groups: Criteria and Policies. Regulatory Review and Innovation 4/28/2009
5100.5 Office of Translational Sciences An Integrated Genomics, Pharmacometrics, and Clinical Pharmacology Review Process Regulatory Review and Innovation 6/16/2010
5210.4 Rev 2 Office of Generic Drugs Review of Bioequivalence Studies with Clinical Endpoints in ANDAs Generic Drug Review 6/22/2017
5210.5 Rev.2 Office of Generic Drugs Review of Investigational New Drug Applications (Bio-INDs) by the Office of Generic Drugs Generic Drug Review 10/25/2016
5230.3 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 2/12/2013
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 4/9/2018
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
6010.6 Office of New Drugs The Use of Clinical Source Data in the Review of Marketing Applications New Drug Review 10/18/2010
6010.5 Office of New Drugs NDAs: Filing Review Issues New Drug Review 3/27/2018
6010.4 Office of Translational Sciences Good Review Practice: Statistical Review Template Regulatory Review and Innovation 9/23/2014
6010.3 Rev.1 Office of New Drugs Good Review Practice: Clinical Review Template New Drug Review 12/10/2010
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 11/8/2016
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.3 Office of the Center Director Drug Shortage Management Medical Policy 11/30/2018
6002.4 Office of New Drugs Government-Issued Nonaccountable Personal Property New Drug Review 8/22/2016
6001.1 Office of Executive Programs Special Government Employees Representing Sponsors Before CDER Executive Secretariat 4/22/1996
5310.7 Rev.1 Office of Pharmaceutical Quality Acceptability of Standards From Alternative Compendia (BP/EP/JP) Regulatory Review and Scientific Policies 9/20/2017
5310.3 Rev.1 Office of Pharmaceutical Quality Requests for Expedited Review of NDA Chemistry Supplements Regulatory Review and Scientific Policies 4/26/2018
6030.1 Rev.3 Office of New Drugs IND Process and Review Procedures (Including Clinical Holds) New Drug Review 2/20/2018
6025.3 Office of New Drugs Good Review Practice: Clinical Consultative Review of Drugs Regulated Within OND New Drug Review 5/16/2017
6025.1 Office of New Drugs Good Review Practices New Drug Review 2/27/2017
6020.14 Office of New Drugs Interdisciplinary Review Team for QT Studies New Drug Review 2/3/2012
6020.13 Office of New Drugs Good Review Practice: Clinical and Consultative Review of Drugs to Reduce the Risk of Cancer New Drug Review 5/16/2017
6020.8 Rev 1 Office of New Drugs Action Packages for NDAs and Efficacy Supplements New Drug Review 6/14/2016
6020.7 Rev.1 Office of New Drugs NDAs: Foreign Language Labeling New Drug Review 10/27/2014
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
7700.3 Office of Translational Sciences CDER Science Projects Database Regulatory Review and Innovation 5/10/2010
7700.2 Office of Translational Sciences Review and Conduct of Human Subject Research Regulatory Review and Innovation 5/18/2009
7700.1 Office of Translational Sciences Management of the Regulatory Science and Review Enhancement (RSR) Committee Regulatory Review and Innovation 11/4/2014
7610.2 Rev.1 Office of Strategic Programs Use of Government Electronic Equipment and Systems Information Technology 11/16/2012
7600.6 Rev.1 Office of Strategic Programs Requesting and Accepting Non-Archivable Records in Electronic Format for New Drug Applications Information Technology 9/3/2013
7600.3 Rev.1 Office of Strategic Programs Maintaining CDER'S Electronic Submissions Docket (Accepting submissions and records in electronic format) Information Technology 5/21/2013
7500.2 Rev.1 Office of New Drugs Regulatory Project Management Site Tours and Regulatory Interactions Program New Drug Review 5/2/2017
7500.1 Rev. 2 Office of New Drugs Regulatory Project Management Coordinating Committee New Drug Review 9/5/2018
7400.4 Rev.1 Office of New Drugs Tertiary Review of Genetic Toxicology Studies Resulting in a Recommendation for a Clinical Hold or Conduct of Additional Studies New Drug Review 2/25/2015
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.1 Office of Surveillance and Epidemiology Procedures for Handling Requests for Proprietary Name Review Drug Safety 1/8/2016
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 3/1/2012
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
6700.2 Office of Surveillance and Epidemiology Standards for Data Management and Analytic Processes in the Office of Surveillance and Epidemiology (OSE) Drug Safety 3/3/2008
6610.1 Rev. 1 Office of Translational Sciences Statistical Policy Coordinating Committee Regulatory Review and Innovation 3/9/2016
6050.1 Rev.1 Office of New Drugs Refusal to Accept Application for Filing From Applicants in Arrears New Drug Review 4/18/2012
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.1 Office of Generic Drugs ANDA Suitability Petitions Generic Drug Review 8/10/2018
7610.5 Office of Strategic Programs Government Issued Computers For CDER Employees Information Technology 4/9/2014
7620.6 Office of Strategic Programs Preparation of Topics and Nomination of Experts For Development and Harmonization of International Scientific and Technical Guidelines Information Technology 9/25/2013
7610.6 Office of Strategic Programs CDER Electronic Application Forms Oversight Information Technology 10/3/2013
6025.4 Office of New Drugs Good Review Practice: Refuse to File New Drug Review 9/5/2018
4657.4 Office of Management Intra-Center Detail Program Staff Resources and Services 11/25/2013
6025.2 Office of New Drugs Good Review Practice: Clinical Review of Investigational New Drug Applications New Drug Review 3/5/2018
4643.9 Rev.1 Office of Management Change in Duty Station Staff Resources & Services 5/6/2019
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 9/28/2018
4655 Office of Management Reference Checks Staff Resources and Services 6/10/2014
4643.4 Office of Management CDER OFFICE SPACE REQUESTS Staff Resources and Services 6/18/2014
4657.12 Rev.1 Office of Management Voluntary Leave Transfer Program Staff Resources and Services 6/24/2014
4643.5 Office of Management CONFERENCE ROOM MANAGEMENT Staff Resources and Services 7/17/2014
6025.6 Office of New Drugs Good Review Practice: Management of Breakthrough Therapy-Designated Drugs and Biologics New Drug Review 7/29/2014
4130.1 Office of the Center Director Drug Development Tool Qualification Programs Leadership and Mission 7/30/2014
5016.3 Office of Pharmaceutical Quality Responsibility in OPQ for the Integrated Quality Assessment of Products Containing Drug Substances Composed of Amino Acid Polymers Regulatory Review and Scientific Policies 12/11/2018
5016.4 Office of Pharmaceutical Quality Clarification Teleconferences Between Sponsors, Applicants, or Master File Holders And the ONDQA Review Team Regulatory Review and Scientific Policies 8/1/2014
4643.2 Office of Management CDER Copier Management Program Staff Resources and Services 9/18/2014
7600.11 Office of Strategic Programs CDER System of Record Information Technology 9/29/2014
4100.1 Rev.1 Office of Management CDER Co-Sponsorship Agreements for Events Staff Resources and Services 8/2/2016
4643.1 Office of Management WORKPLACE ERGONOMIC EVALUATION REQUESTS Staff Resources and Services 10/22/2014
7700.5 Office of Translational Sciences Critical Path Innovation Meetings Policy and Procedures Regulatory Review and Innovation 11/6/2014
5015.1 Office of Pharmaceutical Quality Chemistry Review of Question-based Review (QbR) Submissions Regulatory Review and Scientific Policies 11/19/2014
4001.1 Office of Managment Developing, Issuing and Maintaining Standard Operating Procedures for CDER Staff Resources and Services 1/12/2015
4657.5 Rev.3 Office of Management Advanced Annual and Sick Leave Staff Resources and Services 2/25/2015
6025.7 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 3/9/2015
4651.4 Office of Management CDER Incentive Awards Program (Cash and Time-off) Staff Resources and Services 3/10/2015
4631.4 Office of Management Monitoring and De-obligating Undelivered Orders (UDOs) Staff Resources and Services 6/16/2015
4800.2 Office of the Center Director Continuity of Operations (COOP) Leadership and Mission 5/5/2016
7610.7 Office of Strategic Programs CDER Data Standards Program Information Technology 9/16/2015
4657.11Rev.1 Office of Management Religious Compensatory Time Staff Resources and Services 10/13/2015
5241.2 Office of Generic Drugs Consolidation of ANDAs by the Office of Generic Drugs Generic Drug Review 10/26/2015
6001.2 Office of the Center Director CDER Network Of Experts Leadership and Mission 10/28/2015
5018.2 Office of Pharmaceutical Quality NDA Classification Codes Regulatory Review and Scientific Policies 11/3/2015
5200.7 Office of Generic Drugs Review of ANDA Amendments and Supplements by the Division of Filing Review Generic Drug Review 11/9/2015
4670.2 Office of Management OFFICE OFMANAGEMENT Administrative Leave Requests Related to Performance and Misconduct Staff Resources and Services 11/10/2015
4651.3 Office of Management PHS Commissioned Corps Awards Staff Resources and Services 11/19/2015
4200.5 Office of the Center Director Transfer of CDER Central Funds to Support Intercenter Science Projects Leadership and Mission 3/7/2016
4410.1Rev. 1 Office of Communications FDA Pharmacy Student Experiential Program Public Outreach 12/29/2015
5240.3 Rev.4 Office of Generic Drugs Prioritization of the Review of Original ANDAs, Amendments, and Supplements Generic Drug Review 11/9/2017
5022 Office of Pharmaceutical Quality CDER Liaisons to Official Compendia and Standards Development Organizations – Selection Process, Roles, and Responsibilities Regulatory Review and Scientific Policies 5/10/2016
4640.2 Office of Management Internal Organizational Charts Staff Resources and Services 6/30/2016
         
5016.6 Office of Pharmaceutical Quality Change in Hard Gelatin Capsule Shell Supplier Regulatory Review and Scientific Policies 8/15/2016
6720.4 Office of Surveillance and Epidemiology Procedures for Sharing Non-public Information on Pending Proposed Proprietary Names Drug Safety 9/20/2016
4301.2 Office of Medical Policy Safety Outcomes Trials Subcommittee Medical Policy 11/28/2016
4100.2 Office of Translational Sciences CDER Staff Participation in Public Private Partnerships and Consortia Regulatory Review and Innovation 12/9/2016
5021.1 Office of Pharmaceutical Quality Naming of Drug Products Containing Salt MAPP 5021.1 Regulatory Review and Scientific Policies 12/7/2017
4643.6 Office of Management CDER Scheduling of WO51/1300 Conference Room Staff Resources and Services 4/19/2017
4658.4 Office of Management CDER FTE Tracking and Table of Organization Review Process Staff Resources and Services 5/30/2017
6021.1 Office of New Drugs NDAs/BLAs: Financial Disclosure New Drug Review 6/21/2017
6030.3 Office of New Drugs Emergency Investigational New Drug Application Process During and After Normal Business Hours New Drug Review 9/5/2018
5200.14 Office of Generic Drugs Filing Review of Abbreviated New Drug Applications Generic Drug Review 9/1/2017
7610.8 Office of Strategic Programs Electronic and Digital Signatures for Records Management Information Technology 9/20/2017
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 9/20/2017
5015.12 Office of Pharmaceutical Quality Process for Evaluating Emerging Technologies Related to Quality Regulatory Review and Scientific Policies 9/28/2017
5220.3 Office of Generic Drugs Communicating Certain Deficiencies Identified During Filing Review of ANDAs Generic Drug Review 9/28/2017
5220.1 Office of Generic Drugs Receiving and Processing a Request for Voluntary Withdrawal of an Approved ANDA Generic Drug Review 10/4/2017
5200.12 Office of Generic Drugs Communicating Abbreviated New Drug Application Review Status Updates with Industry Generic Drug Review 10/6/2017
6010.11 Office of the Center Director Developing and Issuing Drug Trial Snapshots Drug Safety 10/26/2017
5220.5 Office of Generic Drugs Issuance of Information Requests and/or Discipline Review Letters for Abbreviated New Drug Applications Generic Drug Review 12/15/2017
5232.1 Office of Compliance PROCESS FOR THE TRANSFER OF OAI CASES FROM OSIS TO OSI Compliance 12/19/2017
5232.2 Office of Compliance Process for Handling OSIS Non-Concurrence with Decision to Downgrade EIR Classification at or after SAM Compliance 12/19/2017
5017.2 Rev.1 Office of Pharmaceutical Quality Establishing Impurity Acceptance Criteria As Part of Specifications for NDAs, ANDAs, and BLAs Based on Clinical Relevance Regulatory Review and Scientific Policies 9/19/2018
5241.3 OFFICE OF GENERIC DRUGS AND OFFICE OF PHARMACEUTICAL QUALITY Good Abbreviated New Drug Application Assessment Practices Generic Drug Review / Regulatory Review and Scientific Policies 1/3/2018
7610.3 Office of Strategic Programs CDER Division IT Coordinator Services Information Technology 2/26/2018
4657.13 Office of Management Compensatory Time Off for Travel Staff Resources and Services 6/4/2018
5014.1 Office of Pharmaceutical Quality Understanding CDER's Risk-Based Site Selection Model Regulatory Review and Scientific Policies 9/5/2018
5231.1 Office of Compliance CDER Barcode Inquiries Compliance 10/2/2018

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