About FDA

Manual of Policies & Procedures (CDER)

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). 

Below is a sortable listing of the CDER MAPPs.

MAPP #OfficeTitleCategoryDate Posted
4000.2 Office of Regulatory Policy Developing and Issuing Guidance (PDF - 78KB) Regulatory Policy and Information Disclosure 10/03/05
4000.1 Rev4 Office of Management Developing and Issuing MAPPs for CDER (PDF - 115KB) Staff Resources and Services 09/18/14
4000.3 Office of Regulatory Policy Submitting Proposals to the Office of Regulatory Policy (ORP) for Early Analysis of Rulemaking Initiatives (PDF - 21KB) Regulatory Policy and Information Disclosure 10/23/01
4000.4 Rev 1 Office of Translational Sciences Good Review Practices: Clinical Pharmacology Review of New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs) (PDF - 307KB) Regulatory Review and Innovation 09/22/16
4000.10 Rev.1 Office of New Drugs Developing Indication-Specific Guidances (PDF - 106KB) New Drug Review 11/21/14
4151.7 Office of the Center Director Joint Safety Meetings Between OND and OSE (PDF - 198KB) Leadership and Mission 03/26/09
4151.3 R4 Office of the Center Director Drug Safety Oversight Board (PDF - 171KB) Leadership and Mission 09/13/16
4151.4 Office of Translational Sciences Multi-Disciplinary Procedures for Managing End-Of-Phase 2A Meeting (PDF - 136KB) Regulatory Review and Innovation 05/04/10
4151.2Rev.1 Office of the Center Director Resolution of Differing Professional Opinions: Review by Ad Hoc Panel and CDER Director (PDF - 113KB) Leadership and Mission 10/12/10
4151.1Rev.1 Office of the Center Director Scientific / Regulatory Dispute Resolution for Individuals Within a Management Chain (PDF - 86KB) Leadership and Mission 10/12/10
4150.1 Office of Executive Programs Role and Procedures of the CDER Ombudsman (PDF - 125KB) Executive Secretariat 10/18/02
4140.6 Office of Regulatory Policy Editing Procedures (PDF - 109KB) Regulatory Policy and Information Disclosure 12/11/02
4140.5 Office of Regulatory Policy Submitting Issues/Documents to the Office of the Chief Counsel (OCC) for Legal Review, Comment, or Clearance (PDF - 22KB) Regulatory Policy and Information Disclosure 03/22/02
4121.2 Office of the Center Director Tracking of Significant Safety Issues in Marketed Drugs -- Use of the DARRTS Tracked Safety Issue (PDF - 100KB) Leadership and Mission 01/04/12
4112.2 Office of Executive Programs Sharing Nonpublic Information with Federal Government Officials. (PDF - 50KB) Regulatory Policy and Information Disclosure 07/12/02
4151.8 Office of the Center Director Equal Voice: Discipline and Organizational Component Collaboration in Scientific and/or Regulatory Decisions (PDF - 106KB) Leadership and Mission 10/12/10
4151.15 Office of the Center Director Collaboration in Managing the CDER Drug Quality Oversight Program (PDF - 131KB) Leadership and Mission 02/01/13
4160.2 Office of Stategic Programs Prioritization of Requests for Training and Visits by Foreign Regulatory Agencies and International Regulatory Organizations (PDF - 29KB) Information Technology 05/31/00
4180.4 Office of New Drugs NDAs/BLAs: Using the 21st Century Review Process Desk Reference Guide (PDF - 51KB) New Drug Review 03/17/15
4180.3 Office of Translational Sciences Processing and Reviewing Voluntary Genomic Data Submissions (VGDSs) (PDF - 146KB) Regulatory Review and Innovation 03/22/05
4180.2 Office of Translational Sciences Management of the Interdisciplinary Pharmacogenomics Review Group (IPRG) (PDF - 149KB) Regulatory Review and Innovation 03/22/05
7400.13 Office of New Drugs Determining the Established Pharmacologic Class for Use in the Highlights of Prescribing Information (PDF - 147KB) New Drug Review 07/18/13
7600.10 Office of Strategic Programs CDER Master Data Management (PDF - 135KB) Information Technology 07/18/13
4200.1 Office of the Center Director Consulting the Controlled Substance Staff on INDs and ProtocolsThat Use Schedule I Controlled Substances and Drugs (PDF - 89KB) Leadership and Mission 05/14/03
4200.2 Office of the Center Director Forecasting Schedule I and II Substance and Drug Needs (PDF - 90KB) Leadership and Mission 05/14/03
4200.3 Rev.1 Office of the Center Directory Consulting the Controlled Substance Staff on Drug Abuse Potential and Labeling, Drug Scheduling, Dependence Liability and Drug Abuse Risks to the Public Health (PDF - 112KB) Drug Safety 03/06/17
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 (PDF - 134KB) Leadership and Mission 02/09/11
4301.1Rev.1 Office of Medical Policy Center for Drug Evaluation and Research Medical Policy Council (PDF - 145KB) Medical Policy 09/14/15
4400.1 Office of Executive Programs Guide to the Orientation Program in the Center for Drug Evaluation and Research (PDF - 204KB) Executive Secretariat 07/18/11
4400.3 Office of Executive Programs CDER Federated Training Model (PDF - 192KB) Executive Secretariat 07/18/11
4655.3 Rev.2 Office of Management Procedures for CDER Medical Officer Conversion to Career-Conditional (PDF - 113KB) Staff Resources and Services 07/11/16
4652.1 Office of Management Property Management Program (PDF - 998KB) Staff Resources and Services 03/29/12
4643.8 Office of Management Relocation Program (PDF - 266KB) Staff Resources and Services 01/18/17
4642.1 Office of Management Policies and Procedures for Organizational Changes (PDF - 38KB) Staff Resources and Services 05/04/07
4641.8 Rev.1 Office of Management Reimbursement for Professional Liability Insurance (PDF - 27KB) Staff Resources and Services 03/14/14
4641.3 Office of Management Outside Activities (PDF - 113KB) Staff Resources and Services 08/08/08
4631.2 Office of Management Preparation of Purchase/Service/Stock Requisitions in iProcurement (PDF - 21KB) Staff Resources and Services 06/20/13
4631.1 Rev.1 Office of Management Supplement to Authority to Make Allotments and Authorize the Establishment of Allowances (PDF - 36KB) Staff Resources and Services 06/20/13
4602.1 Office of Management Telephone Coverage and Responsiveness (PDF - 27KB) Staff Resources and Services 03/28/12
4601.3 Rev.1 Office of Management Children in the Workplace (PDF - 87KB) Staff Resources and Services 04/13/15
4516.1 Office of Communications Criteria for Developing and Publishing Digital Content on the CDER External Web Site (PDF - 635KB) Public Outreach 12/28/12
4515.1 Office of Communications Email best practices (PDF - 114KB) Public Outreach 05/21/13
4512.2 Rev.1 Office of Communications Conducting Effective Meetings in CDER: Remote Access Considerations (PDF - 113KB) Public Outreach 05/20/15
4510.2 Rev.2 Office of Communications CDER Clearance of FDA-Related Articles, Speeches, and Other Publications (PDF - 153KB) Public Outreach 10/22/13
4510.1 Rev.1 Office of Communications CDER Authorization and Tracking of Outside Speaker Clearance (PDF - 141KB) Public Outreach 04/10/13
4520.1 Rev. 1 Office of Communications Communicating Drug Approval Information (PDF - 331KB) Public Outreach 08/28/14
5017.1 Office of Pharmaceutical Quality Office of Biotechnology Products and Office of Compliance, Office of Manufacturing Quality Interactions on BLA Assessments (PDF - 111KB) Regulatory Review and Scientific Policies 10/23/15
4658.3 Rev.3 Office of Management Requesting New Full -Time Equivalents (PDF - 656KB) Staff Resources and Services 12/08/15
4657.9 Rev.4 Office of Management Restoration of Forfeited Annual Leave (PDF - 128KB) Staff Resources and Services 07/09/14
4657.0 Office of Management CDER's Time, Attendance, and Leave Recording Policy (PDF - 33KB) Staff Resources and Services 05/04/07
5015.7 Office of Pharmaceutical Quality Environmental Assessments (PDF - 123KB) Regulatory Review and Scientific Policies 03/17/03
5015.6 Rev.1 Office of Pharmaceutical Quality Review of Grouped Product Quality Supplements (PDF - 90KB) Regulatory Review and Scientific Policies 04/19/16
5015.5 Rev.1 Office of Pharmaceutical Quality CMC Reviews of Type III DMF's for Packaging Materials (PDF - 92KB) Regulatory Review and Scientific Policies 08/12/11
5015.8 Office of Pharmaceutical Quality Acceptance Criteria for Residual Solvents_MAPP (PDF - 64KB) Regulatory Review and Scientific Policies 06/28/17
5016.1 Office of Pharmaceutical Quality Applying ICH Q8(R2), Q9, and Q10 Principles to CMC Review (PDF - 70KB) Regulatory Review and Scientific Policies 05/17/16
5040.1 Office of Pharmaceutical Quality Product Quality Microbiology Information in the Common Technical Document - Quality (CTD-Q) (PDF - 89KB) Regulatory Review and Scientific Policies 01/25/17
5100.3 Office of Translational Sciences OCP Prioritization, Triage, and Review Process for INDs and Pre-INDs (PDF - 129KB) Regulatory Review and Innovation 05/30/06
5100.4 Office of Translational Sciences Scientific Interest Groups: Criteria and Policies. (PDF - 43KB) Regulatory Review and Innovation 04/28/09
5100.5 Office of Translational Sciences An Integrated Genomics, Pharmacometrics, and Clinical Pharmacology Review Process (PDF - 144KB) Regulatory Review and Innovation 06/16/10
5210.4 Rev 2 Office of Generic Drugs Review of Bioequivalence Studies with Clinical Endpoints in ANDAs (PDF - 71KB) Generic Drug Review 06/22/17
5210.5 Rev.2 Office of Generic Drugs Review of Investigational New Drug Applications (Bio-INDs) by the Office of Generic Drugs (PDF - 126KB) Generic Drug Review 10/25/16
5241.1 Office of Generic Drugs Reviewer Determination of Major/Minor Amendments to Abbreviated New Drug Applications (ANDAs) (PDF - 53KB) Generic Drug Review 10/02/12
5230.3 Office of Generic Drugs Generic Drug Labeling Revisions Covered Under Section 505(j)(10) of the Federal Food, Drug, and Cosmetic Act (PDF - 83KB) Generic Drug Review 02/12/13
5225.1 Office of Pharmaceutical Quality Guidance on the Packaging of Test Batches (PDF - 51KB) Regulatory Review and Scientific Policies 09/25/12
5210.7 Office of Generic Drugs Inspections of Clinical Facilities and Analytical Laboratories Conducting Bioequivalence Studies Submitted in ANDAs (PDF - 49KB) Generic Drug Review 09/20/12
6020.4 Rev.2 Office of New Drugs Classifying Resubmissions of Original NDAs, BLAs, and Efficacy Supplements in Response to Action Letters (PDF - 158KB) New Drug Review 02/26/15
6020.2 Rev.1 Office of New Drugs Applications for Parenteral Products in Plastic Immediate Containers (PDF - 37KB) New Drug Review 02/01/13
6010.9 Office of New Drugs Procedures and Responsibilities for Developing Postmarketing Requirements and Commitments (PDF - 290KB) New Drug Review 03/09/09
6010.8 Rev.1 Office of New Drugs NDAs and BLAs: Communication to Applicants of Planned Review Timelines (PDF - 155KB) New Drug Review 08/25/14
6010.6 Office of New Drugs The Use of Clinical Source Data in the Review of Marketing Applications (PDF - 119KB) New Drug Review 10/18/10
6010.5 Office of New Drugs NDAs and BLAs: Filing Review Issues (PDF - 76KB) New Drug Review 12/17/13
6010.4 Office of Translational Sciences Good Review Practice: Statistical Review Template (PDF - 244KB) Regulatory Review and Innovation 09/23/14
6010.3 Rev.1 Office of New Drugs Good Review Practice: Clinical Review Template (PDF - 775KB) New Drug Review 09/18/13
6010.2 Office of New Drugs Responsibilities for Tracking and Communicating the Status of Postmarketing Requirements and Commitments (PDF - 142KB) New Drug Review 07/28/09
5210.9 Rev.1 Office of Pharmaceutical Quality Review of Botanical Drug Products (PDF - 206KB) Regulatory Review and Scientific Policies 11/08/16
6004.2 Rev.1 Office of New Drugs Procedures for Completing and Processing the Form "Annual Status Report Review Form: PMR and PMC Summary" (PDF - 310KB) New Drug Review 10/26/11
4190.1 Rev.2 Office of the Center Director Drug Shortage Management (PDF - 1.1MB) Medical Policy 09/04/14
6002.4 Office of New Drugs Government-Issued Nonaccountable Personal Property (PDF - 85KB) New Drug Review 08/22/16
6001.1 Office of Executive Programs Special Government Employees Representing Sponsors Before CDER (PDF - 13KB) Executive Secretariat 04/22/96
5310.7 Office of Pharmaceutical Quality Acceptability of Standards From Alternative Compendia (BP/EP/JP) (PDF - 66KB) Regulatory Review and Scientific Policies 01/25/17
5310.3 Office of Pharmaceutical Quality Requests for Expedited Review of NDA Chemistry Supplements (PDF - 26KB) Regulatory Review and Scientific Policies 07/02/99
6030.1 Office of New Drugs IND Process and Review Procedures (Including Clinical Holds) (PDF - 32KB) New Drug Review 05/01/98
6025.3 Office of New Drugs Good Review Practice: Clinical Consultative Review of Drugs Regulated Within OND (PDF - 90KB) New Drug Review 05/16/17
6025.1 Office of New Drugs Good Review Practices (PDF - 59KB) New Drug Review 02/27/17
6020.14 Office of New Drugs Interdisciplinary Review Team for QT Studies (PDF - 136KB) New Drug Review 02/03/12
6020.13 Office of New Drugs Good Review Practice: Clinical and Consultative Review of Drugs to Reduce the Risk of Cancer (PDF - 75KB) New Drug Review 05/16/17
6020.10 Office of New Drugs NDAs: "Dear Health Care Professional" Letters (PDF - 114KB) New Drug Review 07/02/03
6020.8 Rev 1 Office of New Drugs NDAs/BLAs/Efficacy Supplements: Action Packages and Taking Regulatory Actions (PDF - 282KB) New Drug Review 06/14/16
6020.7 Rev.1 Office of New Drugs Foreign Language Labeling (PDF - 68KB) New Drug Review 10/27/14
6020.5 Office of New Drugs Good Review Practice: OND Review Management of INDs and NDAs for Nonprescription Drug Products (PDF - 107KB) New Drug Review 07/12/07
7700.3 Office of Translational Sciences CDER Science Projects Database (PDF - 103KB) Regulatory Review and Innovation 05/10/10
7700.2 Office of Translational Sciences Review and Conduct of Human Subject Research (PDF - 199KB) Regulatory Review and Innovation 05/18/09
7700.1 Office of Translational Sciences Management of the Regulatory Science and Review Enhancement Program (PDF - 873KB) Regulatory Review and Innovation 11/04/14
7610.2 Rev.1 Office of Strategic Programs Use of Government Electronic Equipment and Systems (PDF - 64KB) Information Technology 11/16/12
7600.8 Rev.1 Office of Strategic Programs CDER Informatics Governance Process (PDF - 308KB) Information Technology 06/06/13
7600.6 Rev.1 Office of Strategic Programs Requesting and Accepting Non-Archivable Electronic Material for CDER Applications (PDF - 104KB) Information Technology 09/03/13
7600.3 Rev.1 Office of Strategic Programs Maintaining CDER'S Electronic Submissions Docket (Accepting submissions and records in electronic format) (PDF - 164KB) Information Technology 05/21/13
7500.2 Rev.1 Office of New Drugs Regulatory Project Management Site Tours and Regulatory Interactions Program (PDF - 41KB) New Drug Review 05/02/17
7500.1 Office of New Drugs Regulatory Project Management Coordinating Committee (PDF - 76KB) New Drug Review 06/13/13
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 (PDF - 104KB) New Drug Review 02/25/15
7400.1 Rev.2 Office of New Drugs Management of CDER Pharmacology/Toxicology Coordinating Committee and Its Associated Subcommittees and Working Groups (PDF - 118KB) New Drug Review 05/17/16
6730.1 Office of Surveillance and Epidemiology Use of Review Templates in the Office of Surveillance and Epidemiology (PDF - 50KB) Drug Safety 01/25/12
6720.2 Rev.1 Office of Surveillance and Epidemiology Procedures for Handling Requests for Proprietary Name Review (PDF - 228KB) Drug Safety 01/08/16
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) (PDF - 114KB) Drug Safety 03/01/12
6700.9 Office of Surveillance and Epidemiology FDA Posting of Potential Signals of Serious Risks Identified by the Adverse Event Reporting System (PDF - 79KB) Drug Safety 03/29/11
6700.2 Office of Surveillance and Epidemiology Standards for Data Management and Analytic Processes in the Office of Surveillance and Epidemiology (OSE) (PDF - 146KB) Drug Safety 03/03/08
6700.1 Office of New Drugs Risk Management Plan Activities in OND ( the Office of New Drugs) and ODS ( the Office of Drug Safety) (PDF - 46KB) New Drug Review 09/08/05
6610.1 Rev. 1 Office of Translational Sciences Statistical Policy Council (PDF - 161KB) Regulatory Review and Innovation 03/09/16
6050.1 Rev.1 Office of New Drugs Refusal to Accept Application for Filing From Applicants in Arrears (PDF - 76KB) New Drug Review 04/18/12
6030.9 Office of New Drugs Good Review Practice: Good Review Management Principles and Practices for Effective IND Development and Review (PDF - 351KB) New Drug Review 04/29/13
6030.8 Rev.1 Office of New Drugs INDs: Exception from Informed Consent Requirements for Emergency Research (PDF - 283KB) New Drug Review 11/17/14
6030.6 Office of New Drugs INDs: Processing Treatment INDs and Treatment Protocols (PDF - 164KB) New Drug Review 12/09/11
6030.2 Rev.1 Office of New Drugs INDs: Review of Informed Consent Documents (PDF - 183KB) New Drug Review 05/02/14
6020.3 Rev.2 Office of New Drugs Review Designation Policy: Priority (P) and Standard (S) (PDF - 115KB) New Drug Review 06/25/13
6006.1 Office of New Drugs External Recruitment (Civil Service) (PDF - 239KB) New Drug Review 08/08/13
5240.5 Office of Generic Drugs ANDA Suitability Petitions (PDF - 44KB) Generic Drug Review 08/20/13
7610.5 Office of Strategic Programs Government Issued Computers For CDER Employees (PDF - 627KB) Information Technology 04/09/14
5200.3 Rev.1 Office of Generic Drugs Communications with Industry with respect to pre-GDUFA Year Three Abbreviated New Drug Applications (PDF - 75KB) Generic Drug Review 08/18/15
7620.6 Office of Strategic Programs Preparation of Topics and Nomination of Experts For Development and Harmonization of International Scientific and Technical Guidelines (PDF - 652KB) Information Technology 09/25/13
7610.6 Office of Strategic Programs CDER Electronic Application Forms Oversight (PDF - 169KB) Information Technology 10/03/13
6025.4 Office of New Drugs Good Review Practice: Refuse to File (PDF - 267KB) New Drug Review 10/11/13
4657.4 Office of Management Intra-Center Detail Program (PDF - 57KB) Staff Resources and Services 11/25/13
6025.2 Office of New Drugs Good Review Practice: Clinical Review of Investigational New Drug Applications (PDF - 46KB) New Drug Review 12/02/13
4643.9 Rev.1 Office of Management Change in Duty Station (PDF - 211KB) Staff Resources & Services 03/27/14
7412.1 Rev.2 Office of New Drugs Management of CDER Executive Carcinogenicity Assessment Committee and Communication of Committee Proceedings (PDF - 129KB) New Drug Review 12/04/13
7412.2 Rev.1 Office of New Drugs Management of CDER Carcinogenicity Assessment Committee and Communication of Committee Proceedings (PDF - 54KB) New Drug Review 12/04/13
4642.3 Office of Management Student Volunteer Employment Program (SVEP) (PDF - 64KB) Staff Resources and Services 06/06/13
4655.0 Office of Management Reference Checks (PDF - 167KB) Staff Resources and Services 06/10/14
4643.4 Office of Management CDER Office Space Requests (PDF - 455KB) Staff Resources and Services 06/18/14
4657.12 Rev.1 Office of Management Voluntary Leave Transfer Program (PDF - 167KB) Staff Resources and Services 06/19/14
4643.5 Office of Management Conference Room Management (PDF - 143KB) Staff Resources and Services 07/17/14
6025.6 Office of New Drugs Good Review Practice: Management of Breakthrough Therapy-Designated Drugs and Biologics (PDF - 285KB) New Drug Review 07/29/14
4130.1 Office of the Center Director Drug Development Tool Qualification Programs (PDF - 275KB) Leadership and Mission 07/30/14
5016.4 Office of Pharmaceutical Quality Clarification Teleconferences Between Sponsors, Applicants, or Master File Holders And the ONDQA Review Team (PDF - 164KB) Regulatory Review and Scientific Policies 08/01/14
4643.2 Office of Management CDER Copier Management Program (PDF - 64KB) Staff Resources and Services 09/18/14
7600.11 Office of Strategic Programs CDER System of Record (PDF - 103KB) Information Technology 09/29/14
4100.1 Rev.1 Office of Management CDER Co-Sponsorship Agreements for Events (PDF - 695KB) Staff Resources and Services 08/02/16
4643.1 Office of Management Workplace Ergonomic Evaluation Requests (PDF - 142KB) Staff Resources and Services 10/22/14
7700.5 Office of Translational Sciences Critical Path Innovation Meetings Policy and Procedures (PDF - 997KB) Regulatory Review and Innovation 11/06/14
5015.10 Office of Pharmaceutical Quality Chemistry Review of Question-based Review (QbR) Submissions (PDF - 753KB) Regulatory Review and Scientific Policies 11/19/14
4001.1 Office of Managment Developing, Issuing and Maintaining Standard Operating Procedures for CDER (PDF - 73KB) Staff Resources and Services 01/12/15
4657.5 Rev.3 Office of Management Advanced Annual and Sick Leave (PDF - 70KB) Staff Resources and Services 02/25/15
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 (PDF - 217KB) New Drug Review 03/09/15
4651.4 Office of Management CDER Incentive Awards Program (Cash and Time-off) (PDF - 34KB) Staff Resources and Services 03/10/15
4631.4 Office of Management Monitoring and De-obligating Undelivered Orders (UDOs) (PDF - 81KB) Staff Resources and Services 06/16/15
4800.2 Office of the Center Director Continuity of Operations (COOP) (PDF - 206KB) Leadership and Mission 05/05/16
7610.7 Office of Strategic Programs CDER Data Standards Program (PDF - 187KB) Information Technology 09/16/15
4657.11Rev.1 Office of Management Religious Compensatory Time (PDF - 120KB) Staff Resources and Services 10/13/15
5241.2 Office of Generic Drugs Consolidation of ANDAs by the Office of Generic Drugs (PDF - 74KB) Generic Drug Review 10/26/15
6001.2 Office of the Center Director CDER Network Of Experts (PDF - 4MB) Leadership and Mission 10/28/15
5018.2 Office of Pharmaceutical Quality NDA Classification Codes (PDF - 116KB) Regulatory Review and Scientific Policies 11/03/15
5200.7 Office of Generic Drugs Review of ANDA Amendments and Supplements by the Division of Filing Review (PDF - 89KB) Generic Drug Review 11/09/15
4670.2 Office of Management Administrative Leave Requests Related to Performance and Misconduct (PDF - 76KB) Staff Resources and Services 11/10/15
4651.3 Office of Management PHS Commissioned Corps Awards (PDF - 73KB) Staff Resources and Services 11/19/15
4200.5 Office of the Center Director Transfer of CDER Central Funds to Support Intercenter Science Projects (PDF - 2.5MB) Leadership and Mission 03/07/16
4410.1 Office of Communications FDA Pharmacy Student Experiential Program (PDF - 2.7MB) Public Outreach 12/29/15
5240.3 Rev.3 Office of Generic Drugs Prioritization of the Review of Original ANDAs, Amendments, and Supplements (PDF - 107KB) Generic Drug Review 06/27/17
5022.0 Office of Pharmaceutical Quality CDER Liaisons to Official Compendia and Standards Development Organizations – Selection Process, Roles, and Responsibilities (PDF - 80KB) Regulatory Review and Scientific Policies 05/10/16
4640.2 Office of Management Internal Organizational Charts (PDF - 129KB) Staff Resources and Services 06/30/16
4652.2 Office of Management CDER Mobile Device Policy (PDF - 310KB) Staff Resources and Services 08/12/16
5016.6 Office of Pharmaceutical Quality Change in Hard Gelatin Capsule Shell Supplier (PDF - 51KB) Regulatory Review and Scientific Policies 08/15/16
6720.4 Office of Surveillance and Epidemiology Procedures for Sharing Non-public Information on Pending Proposed Proprietary Names (PDF - 92KB) Drug Safety 09/20/16
4301.2 Office of Medical Policy Safety Outcomes Trials Subcommittee (PDF - 74KB) Medical Policy 11/28/16
4100.2 Office of Translational Sciences CDER Staff Participation in Public Private Partnerships and Consortia (PDF - 2.8MB) Regulatory Review and Innovation 12/09/16
5021.1 Office of Pharmaceutical Quality Naming of Drug Products Containing Salt MAPP 5021.1 (PDF - 161KB) Regulatory Review and Scientific Policies 02/20/13
4643.6 Office of Management CDER Scheduling of WO51/1300 Conference Room (PDF - 200KB) Staff Resources and Services 04/19/17
4658.4 Office of Management CDER FTE Tracking and Table of Organization Review Process (PDF - 271KB) Staff Resources and Services 05/30/17
6021.1 Office of New Drugs NDAs/BLAs: Financial Disclosure (PDF - 103KB) New Drug Review 06/21/17

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