-
About FDA
-
Manual of Policies & Procedures (CDER)
This page contains the current CDER Manual of Policies and Procedures (MaPPs) in Adobe Acrobat Format (PDF).
Contents:
Document Development and Management
- 4000.1 Developing and Issuing Manuals of Policies and Procedures (MAPPs) (Issued 3/30/2006; Posted 3/30/2006)
- 4000.2 Developing and Issuing Guidance (Issued 9/13/2005, Posted 10/3/2005)
- 4000.3 Submitting Proposals to the Office of Regulatory Policy (ORP) for Early Analysis of Rulemaking Initiatives (Issued 10/18/2001, Posted 10/23/2001)
- 4000.4 Clinical Pharmacology and Biopharmaceutics NDA Review Template.(Issued 4/27/2004, Posted 6/24/2004).
- 4000.8 BLA Biostatistics Biologics Licensing Application (Issued 4/20/2005, Posted 4/22/2005)
- 4000.8 NDA Biostatistics New Drug Application Review (Issued 4/20/2005, Posted 4/22/2005)
- 4000.10 Indication-Specific Guidance Template (Issued 5/12/2005, Posted 5/12/2005)
Chapter 4100 - Center Director
- 4112.1 CDER/FDA Press Office Interactions in the Preparation and Clearance of Written Documents for the Public (Issued 10/18/2001)
- 4112.2 Sharing Nonpublic Information with Federal Government Officials (Issued 5/9/2002, Posted 7/12/2002)
- 4112.4 Procedures for Assessments Performed by the Quality Assurance Staff (Issued 2/27/2004, Posted 3/25/2004)
- 4112.7 Obtaining the Services of an Expert or Fact Witness for Criminal Cases (Issued 2/27/2004, Posted 3/25/2004)
- 4112.8 Research Coordinating Committee (RCC) (Issued 5/22/2006, Posted 5/22/2006)
- 4114.1 Support Staff Coordinating Committee (Issued 6/11/1999, Posted 7/02/1999)
- 4114.2 Telephone Coverage Policy (Issued 11/26/2002, Posted 12/11/2002)
- 4140.5 Submitting Issues/Documents to the Office of the Chief Counsel (OCC) for Legal Review, Comment, or Clearance (Issued 3/2002, Posted 3/22/2002)
- 4140.6 Editing Procedures(Issued 11/27/2002, Posted 12/11/2002)
- 4143.1 Special Termination of Mandatory Debarment of an Individual (Issued 2/25/1997, Posted 2/25/1997)
- 4150.1 Role and Procedures of the CDER Ombudsman (Issued 10/10/2002, Posted 10/18/2002)
- 4151.1 Resolution of Disputes: Roles of Reviewers, Supervisors, and Management: Documenting Viewsand Findings and Resolving Differences
- 4151.2 Documenting Differing Professional Opinions and Dispute Resolution – Pilot Program (Posted 11/5/2004)
- 4151.3R Drug Safety Oversight Board (DSB) (Issued 3/2/2007, Posted 3/2/2007)
- 4151.6 "Drug Safety Newsletter" (Issued 6/17/2008, Posted 6/19/2008)
- 4151.7R Joint Safety Meetings Between OND and OSE (Issued 3/26/2009; Posted 3/26/2009)
- 4160-2 Prioritization of Requests for Training and Visits by Foreign Regulatory Agencies and International Regulatory Organizations (Issued 5/31/2000)
- 4170-2 Submitting Non-FOIA Requests For Document Collection and Redaction To CDER's Division of Information Disclosure Policy (DIDP) (Issued 5/9/2002, Posted 5/15/2002)
- 4170.3 Litigation Document Control Procedures in the Division of Information Disclosure Policy (Issued 8/10/2003, Posted 12/11/2003)
- 4180.2 Management of the Interdisciplinary Pharmacogenomics Review Group (IPRG) (Issued 3/16/2005, Posted 3/22/2005)
- 4180.3 Processing and Reviewing Voluntary Genomic Data Submissions (VGDSs) (Issued 3/16/2005, Posted 3/22/2005)
Chapter 4200 - Controlled Substances
- 4200.1 Consulting the Controlled Substance Staff on INDs and ProtocolsThat Use Schedule I Controlled Substances and Drugs (Issued 5/8/2003, Posted 5/14/2003)
- 4200.2 Forecasting Schedule I and II Substance and Drug Needs (Issued 5/8/2003, Posted 5/14/2003)
- 4200.3 Consulting the Controlled Substance Staff on Abuse Liability, Drug Dependence, Risk Management, and Drug Scheduling (Issued 5/8/2003, Posted 5/14/2003)
Chapters 4300 - 4400 (Reserved)
Chapter 4500 - Training and Communications
- 4501.1R Alternate Work Schedules for the Office of Training and Communications (Revised 6/1/2007; Posted 6/7/2007)
- 4501.2R Flexible Workplace Arrangements Program (FWAP) for the Office of Training and Communications (Revised 6/1/2007; Posted 6/7/2007)
- 4510.1 Authorization, Funding and Tracking Speeches/Participation on Planning Committees
- 4510.2 Clearance of Speeches, Articles and Other Communication Material (Revised 1/26/1999, Posted 1/26/1999)
- 4520.1 Communicating Drug Approval Information (Issued 3/25/1998, Posted 3/26/1998)
- 4520.2R Providing General Consumer Information on New Molecular Entities on CDER’s Web Site (Issued 10/1/2007, Posted 5/6/2008)
- 4550.1 Participation in the Volunteer Program for Pharmacy Students (Issued 5/12/1998, Posted 5/14/1998)
- 4550.3 Employee Training and Development (Issued 3/13/1997, Posted 3/23/1998)
- 4550.5R Accreditation — Continuing Education (Issued 11/16/2007, Posted 11/19/2007)
- 4550.7R Guide to the Orientation Mentoring Program in the Center for Drug Evaluation and Research (Revised 6/1/2007; Posted 6/7/2007)
Chapter 4600 - Management
- 4601.2R Use of Alternative Workplaces for Commissioned Corps Officers (Issued 2/22/2007, Posted 2/22/2007)
- 4601.3 Children in the Workplace (Issued 10/14/2004, Posted 10/18/2004)
- 4631.1 Supplement to Authority to Make Allotments and Authorize the Establishment of Allowances
- 4631.2R Preparation of Purchase/Service/Stock Requisitions in iProcurement (Issued 10/18/2007, Posted 10/19/2007)
- 4631.3R Budget Execution Planning and Reporting/Program Management System Reports (Issued 4/8/2008, Posted 4/8/2008)
- 4634.3R Development, Maintenance, and Distribution of CDER Organizational Charts (Issued 2/22/2007; Posted 2/22/2007)
- 4636.1R Gift Certificates/Gift Cards (Issued 11/24/2007; Posted 11/26/2007)
- 4640.1R Guide to the Assignment of Mail Routing Codes in the Center for Drug Evaluation and Research (Revised 6/1/2007; Posted 6/7/2007)
- 4641.3R Outside Activities (Revised 7/1/2008; Posted 8/8/2008
- 4641.5 Authority to Reimburse Employees for Business Calls Made on Personal Car Phones (Issued 4/8/2008, Posted 4/8/2008)
- 4641.8 Reimbursement for Professional Liability Insurance (Issued 5/8/2003, Posted 5/14/2003)
- 1164 Form - Claim for Reimbursement Expenditures on Official Business
- 4642.1R Policies and Procedures for Organizational Changes (Issued 4/25/07 Posted 5/4/2007)
- 4651.1 On-the-Spot Cash Award
- 4651.2R Time Off Incentive Award (Revised 1/9/2008; Posted 1/9/2008)
- 4655.2 Performance Management Program (Issued 5/12/1998, Posted 5/14/1998)
- 4656.1 CDER Expert Regulatory Scientist Peer Review Committee (Issued 6/19/2003, Posted 10/2/2003)
- 4657-0R CDER's Time, Attendance, and Leave Recording Policy (Issued 4/25/07 Posted 5/4/2007)
- 4657.1R Alternate Work Schedules (AWS) (Revised 6/10/2008; Posted 6/10/2008)
- 4657.2R (FWAP) Flexiplace and Work at Home (Revised 1/9/2008; Posted 1/9/2008)
- 4657.5R Advanced Annual and Sick Leave (Revised 11/1/2006, Posted 11/2/2006)
- 4657.6R Granting Excused Absence (Originator: Division of Management Services, OM) (Issued 4/25/07 Posted 5/4/2007)
- 4657.7R Leave and Absence for Hazardous Weather and Other Emergency and Administrative Situations (Revised) (Originator: Division of Management Services, OM; Issued Updated 5/5/2006, Posted 6/7/2006)
- 4657.9R Restoration of Forfeited Annual Leave (Issued 1/13/2006, Posted 1/20/2006)
- 4657.10 Hazardous Weather Policy for Employees with Disabilities (Issued 2/19/1997, Posted 2/21/1997)
- 4657.11R Religious Compensatory Time (Issued 4/25/07 Posted 5/4/2007)
- 4657.12 Voluntary Leave Transfer Program (Issued 11/7/1997, Posted 12/8/1997)
Chapter 4700 - Compliance
- 4700.1 Management of CDER Compliance Coordinating Committee (Issued 3/4/1997, Posted 3/18/1997)
- 4703.1 Alternate Work Schedules for the Office of Compliance (Originator: Director, Office of Compliance; Issued 11/19/96)
- 4703.2 Flexible Workplace Arrangements Program for the Office of Compliance (Originator: Director, Office of Compliance; Issued 11/19/96)
- 4723.1 Standing operating Procedures for NDA/ANDA Field alert Reports (Issued 10/30/1998, Posted 11/02/1998)
Chapter 4800.4900 (Reserved)
Chapter 5000 - Pharmaceutical Sciences
- 5000.4 CDER Office of Pharmaceutical Science Immediate Office Calendar (Issued 5/8/2003,Posted 5/14/2003)
- 5000.5 Office of Pharmaceutical Science Regulatory and Scientific Briefings (Issued 6/22/2004, Posted 6/24/2004)
- 5000.6 Office of Pharmaceutical Sciences Coordinating Committee (OPS CC) (Issued 6/14/2006, Posted 6/14/2006)
- 5015.3 Cover Form for the Technical Review of Drug Master Files (Issued 3/23/1998, Posted 4/7/1998)
- 5015.4 Chemistry Reviews of DMFs for Drug Substances/Intermediates (DSI) (Issued 8/17/98, Posted 10/7/98)
- 5015-6 Review of the Same Supplemental Change to More than One NDA or ANDA in More Than One Review Division (Issued 1/14/2000, Posted 1/19/2000)
- 5015.7 Environmental Assessments (Issued 3/6/2003, Posted 3/17/2003)
- 5015.8 Acceptance Criteria for Residual Solvents (Issued 3/10/2009; Posted 3/11/2009)
- 5020.1R Responding to Telephone Inquiries in the Office of Generic Drugs (Issued 8/1/2006; Posted 8/3/2006)
- 5040.1 Product Quality Microbiology Information in the Common Technical Document - Quality (CTD-Q) (Issued 5/24/2004)
Chapter 5100 - Clinical Pharmacology
- 5100.3 OCP Prioritization, Triage, and Review Process for INDs and Pre-INDs (Issued 5/26/2006; Posted 5/30/2006)
- 5100.4 Scientific Interest Groups: Criteria and Policies. (Issued 4/28/2009; Posted 4/28/2009)
- 5120.1 Clinical Pharmacology And Biopharmaceutics (CPB) Briefing Criteria And Attendance Policies (Issued 10/1997, Posted 10/22/1997)
Chapter 5200 - Generic Drugs
- 5200.6 Issuing and Tracking of Consults (Issued 5/9/2001, Posted 5/14/2001)
- 5210.1 Procedure for Public Release of Bioequivalence Protocols and Reviews (MaPP withdrawn because it is obsolete)
- 5200.8 Processing a Tentatively Approved Application to Full Approval (Issued 6/9/2005, Posted 6/23/2005)
- 5200.9 Processing Supplements to Abbreviated New Drug Applications Providing for Alternate Analytical Testing Laboratory Site Changes (Issued 6/22/2005, Posted 6/23/2005)
- 5200.10 Processing of Supplemental Applications Providing for Alternate Stand Alone Packaging Operation Site Changes (Issued 6/9/2005, Posted 6/23/2005)
- 5200.11 Procedures for Post-Approval Commitment Tracking in the Office of Generic Drugs (Issued 7/13/2007; Posted 7/16/2007)
- 5210.2 Reassignment of Bioequivalence Reviews (Revised 5/9/2001, Posted 5/14/2001)
- 5210.3R Productivity Documentation in the Division of Bioequivalence (Issued 4/6/2009, Posted 4/6/2009)
- 5210.4R Review Responsibility for Bioequivalence Studies with Clinical Endpoints Submitted in an Abbreviated New Drug Application (Issued 12/12/2006, Posted 12/12/2006)
- 5210.5 Review of Investigational New Drug Applications (Bio-INDs) by the Office of Generic Drugs (Issued 7/7/2006, Posted 7/7/2006)
- 5210.6 Procedures for Review of Bioequivalence Study Protocols (Issued 7/7/2006, Posted 7/10/2006)
- 5210.7 Inspections of Clinical Facilities and Analytical Laboratories (Issued 12/15/2000, Posted 1/3/2001)
- 5210.8R Review of Dissolution Data in Supplemental ANDAs (Issued 8/1/2006, Posted 8/3/2006)
- 5221.1 Requesting Methods Validation for ANDAs (Issued 3/30/2006, Posted 3/30/2006)
- 5223.2 Scoring Configuration of Generic Drug Products
- 5225.1 Guidance on the Packaging of Test Batches
- 5230.2 Review of Generic Drug Product Labeling Requiring Input From Multiple FDA Components (Issued 7/9/2003, Posted 10/2/2003)
- 5240.1 Requests for Expedited Review of Supplements to Approved ANDAs and AADAs
- 5240.3R Review Order of Original ANDAs, Amendments, and Supplements (Issued and posted 10/18/2006)
- 5240.6 Telephone Requests by the Division of Bioequivalence (Issued 12/18/2000, Posted 1/3/2001)
- 5240.7 Telephone Requests by the Divisions of Chemistry (Issued 10/6/2003, Posted 10/8/2003)
- 5240.8 Handling of Adverse Experience Reports and Other Generic Drug Postmarketing Reports (Issued 11/2/1005, Posted 11/2/2005)
- 5240.9 Handling and Processing Requests for Global Reviews (Issued 11/29/2004, Posted 12/17/2004)
Chapter 5300 - New Drug Chemistry
- 5310.2 Drafting, Circulating, and Signing Chemistry, Manufacturing, and Controls Letters (Issued 10/27/1998, Posted 11/02/1998)
- 5310.3 Requests for Expedited Review of NDA Chemistry Supplements (Issued 6/11/1999, Posted 7/02/1999)
- 5310.4 Procedures for Evaluating and Handling Field Alert Reports (Posted 11/3/2000)
- 5310.6 Procedures for Assessing Chemistry, Manufacturing, and Controls Data in NDA Annual Reports (Issued 10/10/2002, Posted 10/18/2002)
- 5310.7R Acceptability of Standards From Alternative Compendia (Issued 11/15/2007; Posted 11/16/2007)
Chapter 5400 - Testing and Research
Chapters 5500.5900 - (Reserved)
Chapter 6000 - Review Management
- 6001.1 Special Government Employees Representing Sponsors Before CDER
- 6002.1 Alternative Work Schedule
- 6002.2 Flexiplace Workplace Agreement Program
- 6002.3 Magnified Maxiflex for ORM (Issued 11/20/1997, Posted 1/16/1998)
- 6003.1 Drug Shortage Management Issued (9/26/2006, Posted 9/28/2006)
- 6004.1 Granting Waivers Under 21 CFR 314.90 for Postmarketing Safety Reporting Requirements Under 21 CFR 314.80 (Issued 11/16/1999, Posted 11/17/1999)
- 6004.2 Procedures for Completing and Processing the Form "Annual Report Review: Postmarketing Study Commitment Summary (Issued 3/10/2005, Posted 3/15/2005)
- 6007.1 Review of Botanical Drug Products (Issued 6/7/2004, Posted 6/9/2004)
- 6010.1 NDAs: Preapproval Safety Conferences (Issued 11/15/1999, Posted 11/17/1999)
- 6010.2R Responsibilities for Tracking and Communicating the Status of Postmarketing Requirements and Commitments
- 6010.3 Clinical Review Template (Issued 7/9/2004, Posted 7/12/2004)
- 6010.5 NDAs: Filing Review Issues (Issued 5/8/2003, Posted 5/14/2003)
- 6010.7 Clinical Hold/Refusal-to-File Committee (Issued 1/9/2008; Posted 1/9/2008)
- 6010.8 NDAs and BLAs: Communication to Applicants of Planned Review Timelines.
- 6010.9 Procedures and Responsibilities for Developing Postmarketing Requirements and Commitments (Issued 3/10/2009; Posted 3/11/2009)
- 6020.1 Extraneous References in Product Labeling: Exclusion of American Hospital Formulary Service (AHFS) Pharmacologic-Therapeutic Classifications
- 6020.2R Applications for Parenteral Products in Plastic Immediate Containters (Issued 4/25/07 Posted 5/4/2007)
- 6020.3R Review Classification Policy: Priority (P) and Standard (S) (Revised 7/18/2007; Posted 7/18/2007)
- 6020.4R Classifying Resubmissions of Original NDAs, BLAs, and Efficiacy Supplements in Response to Action Letters (Issued 11/15/2007, Posted 11/16/2007)
- 6020.5R Good Review Practice: OND Review Management of INDs and NDAs for Nonprescription Drug Products (Issued 7/13/2007, Posted 7/16/2007)
- 6020.7 NDAs: Foreign Language Labeling (Issued 7/9/004, Posted 7/12/2004)
- 6020.8 Action Packages for NDAs and Efficacy Supplements (Issued 11/13/2002, Posted 12/11/2002)
- 6020.10 NDAs: "Dear Health Care Professional" Letters (Issued 7/2/2003, Posted 10/2/2003)
- 6020.13 Clinical Review of Drugs to Reduce the Risk of Cancer (Issued 12/13/2005, Posted 12/15/2005)
- 6020.14 Interdisciplinary Review Team for QT Studies (Issued 10/18/2007; Posted 10/19/2007)
- 6025.1 Good Review Practices (Issued 9/5/2006; Posted 9/7/2006)
- 6025.3 Good Review Practice: Consultative Review of Drugs Regulated Within OND. (Issued 1/12/2007; Posted 1/16/2007)
- 6030.1 IND Process and Review Procedures (Issued 5/1/1998, Posted 5/14/1998)
- 6030.2 INDs: Review of Informed Consent Documents (Issued 11/13/2002, Posted 12/11/2002)
- 6030.4 INDs: Screening INDs (Issued 5/9/2001, Posted 5/14/2001)
- 6030.8 INDs: Exception from Informed Consent Requirements for Emergency Research (Issued 2/4/2003, Posted 3/17/2003)
- 6050.1R Refusal to Accept Application for Filing From Applicants in Arrears (Issued 8/14/2007; Posted 8/21/2007)
- 6060.1R Consulting the Maternal Health Team (Issued 1/5/07, Posted 1/5/07)
Chapter 6100 - Office of Drug Evaluation I
- 6110.1 Time and Attendance Policy for the Division of Oncology Drug Products
Chapter 6200 - Office of Drug Evaluation II
Chapter 6300 - Office of Drug Evaluation III
- 6301.3 Overtime Policy for the Office of Drug Evaluation III (ODE III)
- 6301.4 Time and Attendance Policy for the Office of Drug Evaluation III (Issued 10/20/1997, Posted 12/8/1997)
Chapter 6400 - Office of Drug Evaluation IV
Chapter 6500 - Office of Drug Evaluation V
- 6501.1 Flexible Workplace Arrangements Program for the Office of Drug Evaluation V
- 6501.2 Alternate Work Schedules for the Office of Drug Evaluation V (1/7/1996)
- 6532.1 Over-the-Counter (OTC) Labeling and Use Studies
Chapter 6600 - Epidemiology and Biostatistics
- 6610.1 Statistical Policy Coordinating Committee (Issued 7/28/1999, Posted 7/28/1999)
- 6610.2 Responsibilities and Procedures for Statistical Review and Evaluation of Animal Carcinogenicity Studies (Issued 11/30/2004, Posted 12/17/2004)
Chapter 6700 - Office of Drug Safety
- 6700.1 Risk Management Plan Activities in the Office of New Drugs and the Office of Drug Safety (Issued 9/8/2005, Posted 10/3/2005)
- 6700.2 Standards for Data Management and Analytic Processes in the Office of Surveillance and Epidemiology (OSE) (Issued 3/3/2008; Posted 3/4/2008)
- 6700.4 Tracking of Significant Safety Issues in Marketed Drugs -- Use of the DARRTS Tracked Safety Issue. (Issued 6/8/2009; Posted 6/9/2009
Chapter 7000 - Discipline Specific
Chapter 7100 - Biopharmaceutics
Chapter 7200 - Chemistry
- 7211.1 Drug Application Approval 501(b) Policy
Chapter 7300 - Medical/Statistical
- 7310.1 Medical Officer Evaluation Board (Issued 1/10/2003, Posted 3/17/2003)
Chapter 7400 - Pharmacology and Toxicology
- 7400.1R Management of CDER Pharmacology/Toxicology Coordinating Committee (Issued 10/18/2007; Posted 10/19/2007)
- 7400.4 Tertiary Review of Genetic Toxicology Studies Resulting in a Recommendation for a Clinical Hold or Conduct of Additional Studies (Issued 9/27/2004, Posted 9/28/2004)
- 7400.5 Management of the PTCC Education Subcommittee (Issued 9/9/2004, Posted 9/28/2004)
- 7400.6 Management of the PTCC Inactive (Issued 4/20/2005, Posted 4/22/2005)
- 7400.7 Management of the PTCC Safety Pharmacology Subcommittee (issued 11/29/2004, Posted 12/17/2004)
- 7400.8 Management of the Pharmacology and Toxicology Coordinating Committee Nonclinical Pharmacogenomics Subcommittee (Issued 12/1/2004, Posted 12/17/2004)
- 7400.9 Management of the PTCC Reproductive and Developmental Toxicology Subcommittee (Issued 3/3/2008; Posted 3/4/2008)
- 7412.1 Management of CDER Carcinogenicity Assessment Committee (CAC) and Executive CAC
- 7412.2 Distribution of Final Reports from the Carcinogenicity Assessment Committee (CAC) and the Executive CAC (Issued 3/24/1997, Posted 4/8/1997)
Chapter 7500 - Project Management
- 7500.1R Office of New Drugs Regulatory Project Management Coordinating Committee (Issued 5/15/2008, Posted 5/15/2008)
- 7500.2R Regulatory Project Management Site Tours and Regulatory Interactions Program (Issued 11/1/2006, Posted 11/2/2006)
- 7510.1 Withdrawn, superceded by the provisions of FDAMA Section 116, which went into effect on Novemer 21, 1999 (Issued 12/1998, Posted 12/3/1998)
Chapter 7600 - Information Technology
- 7600.2 Computer Hardware
- 7600.3 Maintaining CDER'S Electronic Submissions Docket (Issued 10/15/1997, Posted 11/14/1997)
- 7600.4 Nomenclature Standards Committee (NSC) (Issued 4/25/1998, Posted 4/28/1998)
- 7600.6 Requesting and Accepting Non-Archivable Records in Electronic Format for New Drug Applications (Issued 11/12/1999, Posted 11/17/1999)
- 7600.7 Processing an Electronic New Drug Application (Issued 5/31/2000, Posted 6/5/2000)
- 7600.9 Information Management Steering Committee (IMSC) Planning Subcommittee (Issued 3/4/2005, Posted 3/15/2005)
- 7610.1 Posting Documents on the External World Wide Web Site
- 7610.2 Use of Government Electronic Equipment and Systems (Issued 5/8/1998, Posted 5/14/1998)
- 7620.4 Time, Attendance, and Leave Recording Policy in the Office of Information Technology (Issued 10/18/2001, Posted 10/23/2001)
- 7620.5 Procedures for Acquisition, Tracking, Distribution, and Safeguarding of Gift Certificates in the Office of Information Technology (Issued 11/20/2001, Posted 11/21/2001)
Chapter 7700 - Office of Translational Sciences
- 7700.1 Management of the Regulatory Science and Review Enhancement Committee (Issued 4/8/2008 Posted 4/8/2008)
- 7700.2 Review and Conduct of Human Subject Research (Issued 5/18/2009; Posted 5/19/2009)
Chapter 7800 - Administrative Management
- 7800.1R Administrative Management Coordinating Committee (Issued 2/22/2007, Posted 2/22/2007)
-
-