Manual of Policies & Procedures (CDER)

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

Questions and/or comments:CDERMAPPTEAM@fda.hhs.gov

Contents:

Document Development and    Management Center Director Controlled Substances Office of Medical Policy Office of Communications Management Compliance Pharmaceutical Sciences Clinical Pharmacology Generic Drugs

New Drug Chemistry Testing and Research Review Management Office of Counter-Terrorism and Emergency Coordination (OCTEC) Office of Executive Programs Office of Drug Evaluation I Office of Drug Evaluation II Office of Drug Evaluation III Office of Drug Evaluation IV Office of Drug Evaluation V Epidemiology and Biostatistics

Office of Surveillance and Epidemiology Office of Prescription Drug Promotion (OPDP) Discipline Specific Biopharmaceutics Chemistry Medical/Statistical Pharmacology and Toxicology Project Management Information Technology Office of Translational Sciences Administrative Management

Chapter 4000 - Document Development and Management 

• 4000.1 Rev3 (PDF - 196KB) Developing and Issuing MAPPs for CDER  (Issued 9/26/2011; Posted 9/26/2011
• 4000.2 (PDF - 78KB) Developing and Issuing Guidance (Issued 9/13/2005, Posted 10/3/2005)
• 4000.3 (PDF - 21KB) 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 (PDF - 332KB) Clinical Pharmacology and Biopharmaceutics NDA Review Template.(Issued 4/27/2004, Posted 6/24/2004).
• 4000.10 (PDF - 104KB) Indication-Specific Guidance Template(Issued 5/12/2005, Posted 5/12/2005)

Chapter 4100 - Center Director

• 4112.1 (PDF - 25KB) CDER/FDA Press Office Interactions in the Preparation and Clearance of Written Documents for the Public (Issued 10/18/2001)
• 4112.2 (PDF - 50KB) Sharing Nonpublic Information with Federal Government Officials (Issued 5/9/2002, Posted 7/12/2002)
• 4112.4 (PDF - 106KB) Procedures for Assessments Performed by the Quality Assurance Staff (Issued 2/27/2004, Posted 3/25/2004)
• 4112.8 (PDF - 28KB) Research Coordinating Committee (RCC) (Issued 5/22/2006, Posted 5/22/2006)
• 4114.1 (PDF - 22KB) Support Staff Coordinating Committee (Issued 6/11/1999, Posted 7/02/1999)
• 4114.2  Telephone Coverage Policy "MAPP temporarily removed for editing and revision. For additional information, contact the CDER MAPP team at cdermappteam@fda.hhs.gov ."
• 4121.2 (PDF - 100KB) Tracking of Significant Safety issues in Marketed Drugs -- Use of the DARRTS Tracked Safety Issues (Issued 1/3/12; Posted 1/4/12) 
• 4140.5 (PDF - 22KB) 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 (PDF - 109KB) Editing Procedures (Issued 11/27/2002, Posted 12/11/2002)
• 4150.1 (PDF - 125KB) Role and Procedures of the CDER Ombudsman (Issued 10/10/2002, Posted 10/18/2002)
• 4151.1R (PDF - 86KB) Scientific/Regulatory Dispute Resolution for Individuals Within a Management Chain  (Issued 10/8/2010; Posted 10/12/2010)
• 4151.2R (PDF - 113KB) Resolution of Differing Professional Opinions: Review by Ad Hoc Panel and CDER Director (Issued 10/8/2010; Posted 10/12/2010)
• 4151.3r3 (PDF - 164KB) Drug Safety Oversight Board (DSB) (Issued 7/8/2010, Posted 7/9/2010)
• 4151.4 (PDF - 54KB) Multi-Disciplinary Procedures for Managing End-of-Phase 2A Meetings (Issued 5/3/2010, Posted 5/4/2010)
• 4151.6 (PDF - 215KB) "Drug Safety Newsletter" (Issued 6/17/2008, Posted 6/19/2008)
• 4151.7R (PDF - 198KB) Joint Safety Meetings Between OND and OSE (Issued 3/26/2009; Posted 3/26/2009)
• 4151.8 (PDF - 106KB) Equal Voice: Discipline and Organizational Component Collaboration in Scientific and/or Regulatory Decisions (Issued 10/8/2010; Posted 10/12/2010)
• 4160-2 (PDF - 29KB) Prioritization of Requests for Training and Visits by Foreign Regulatory Agencies and International Regulatory Organizations (Issued 5/31/2000)
• 4170-2 (PDF - 25KB) 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 (PDF - 165KB) Litigation Document Control Procedures in the Division of Information Disclosure Policy (Issued 8/10/2003, Posted 12/11/2003)
• 4180.2 (PDF - 149KB) Management of the Interdisciplinary Pharmacogenomics Review Group (IPRG) (Issued 3/16/2005, Posted 3/22/2005)
• 4180.3 (PDF - 146KB) Processing and Reviewing Voluntary Genomic Data Submissions (VGDSs) (Issued 3/16/2005, Posted 3/22/2005)
• 4180.4 (PDF - 37KB) NDAs/BLAs:  Using the 21st Century Review Process Desk Reference Guide (Issued 11/8/2010; Posted 11/8/2010)

Chapter 4200 - Controlled Substances

• 4200.1 (PDF - 89KB) 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 (PDF - 91KB) Forecasting Schedule I and II Substance and Drug Needs (Issued 5/8/2003, Posted 5/14/2003)
• 4200.3 (PDF - 96KB) Consulting the Controlled Substance Staff on Abuse Liability, Drug Dependence, Risk Management, and Drug Scheduling (Issued 5/8/2003, Posted 5/14/2003)
• 4200.4 (PDF - 135KB) Office of Generic Drugs (OGD) Consultation with the Controlled Substance Staff (CSS) on Subject Abbreviated New Drug Application (ANDA) Submissions (Issued and Posted 2/9/2011)

Chapters 4300 Office of Medical Policy

 

Sub Chapter 4350 - 4399 Office of Prescription Drug Promotion (OPDP)

 

Chapter 4400 Office of Executive Programs

• 4400.1 Guide to the Orientation Program in the Center for Drug Evaluation and Research (Issued 7/18/2011; Posted 7/18/2011)
• 4400.2 Accreditation -- Continuing Education (Issued 7/18/2011; Posted 7/18/2011)
• 4400.3 CDER Federated Training Model (Issued 7/18/2011; Posted 7/18/2011)

Chapter 4500 - Office of Communications

• 4501.1R (PDF - 35KB) Alternate Work Schedules for the Office of Training and Communications(Revised 6/1/2007; Posted 6/7/2007)
• 4501.2R (PDF - 37KB) Flexible Workplace Arrangements Program (FWAP) for the Office of Training and Communications (Revised 6/1/2007; Posted 6/7/2007)
• 4510.1 (PDF - 27KB) Authorization, Funding and Tracking Speeches/Participation on Planning Committees
• 4510.2 (PDF - 21KB) Clearance of Speeches, Articles and Other Communication Material (Revised 1/26/1999, Posted 1/26/1999)
• 4520.1 (PDF - 20KB) Communicating Drug Approval Information (Removed for updating 1/26/2010)
• 4520.2R (PDF - 43KB)Providing General Consumer Information on New Molecular Entities on CDER’s Web Site (Issued 10/1/2007, Posted 5/6/2008)
• 4550.1 (PDF - 29KB) Participation in the Volunteer Program for Pharmacy Students (Issued 5/12/1998, Posted 5/14/1998)
• 4550.3 rev 2 CDER Federated Training Model (moved to 4400.3)
• 4550.5R Accreditation - Continuing Education (moved to 4400.2)
• 4550.7R  Guide to the Orientation Mentoring Program in the Center for Drug Evaluation and Research (Moved to 4400.1)

Chapter 4600 - Management

• 4601.3 (PDF - 80KB) Children in the Workplace (Issued 10/14/2004, Posted 10/18/2004)
• 4602.1 (PDF - 36KB) Telephone Coverage and Responsiveness (Issued 3/28/2012; Posted 3/28/2012
• 4631.1 (PDF - 10KB) Supplement to Authority to Make Allotments and Authorize the Establishment of Allowances
• 4631.2R (PDF - 23KB) Preparation of Purchase/Service/Stock Requisitions in iProcurement(Issued 10/18/2007, Posted 10/19/2007)
• 4631.3R (PDF - 23KB) Budget Execution Planning and Reporting/Program Management System Reports (Issued 4/8/2008, Posted 4/8/2008)
• 4634.3R (PDF - 23KB) Development, Maintenance, and Distribution of CDER Organizational Charts (Issued 2/22/2007; Posted 2/22/2007)
• 4641.3R (PDF - 113KB) Outside Activities (Revised 7/1/2008; Posted 8/8/2008
• 4641.5 (PDF - 50KB) Authority to Reimburse Employees for Business Calls Made on Personal Car Phones  (Issued 4/8/2008, Posted 4/8/2008)
• 4641.8 (PDF - 92KB) Reimbursement for Professional Liability Insurance  (Issued 5/8/2003, Posted 5/14/2003)
  • 1164 Form - (PDF - 81KB) Claim for Reimbursement Expenditures on Official Business
• 4642.1R (PDF - 38KB) Policies and Procedures for Organizational Changes  (Issued 4/25/07 Posted 5/4/2007)
• 4643.8 (PDF - 174KB)  Relocation Program (Issued and Posted 4/10/2012
• 4651.2R Time Off Incentive Award "MAPP Temporarily Removed for Editing and Revision. For additional information, contact the CDER MAPP Team at cdermappteam@fda.hhs.gov".
• 4652.1 (PDF - 845KB) Property Management Program (Issued and Posted 3/29/2012)
• 4655.2 Performance Management Program "MAPP Temporarily Removed for Editing and Revision. For additional information, contact the CDER MAPP Team at cdermappteam@fda.hhs.gov".
• 4655.3 (PDF - 163KB) Procedures for CDER Medical Officer Conversion to Career-Conditional (Issued and Posted 11/24/2010).
• 4657-0R (PDF - 157KB) CDER's Time, Attendance, and Leave Recording Policy (PDF - 33KB)(Issued 4/25/07 Posted 5/4/2007)
• 4657.1R (PDF - 286KB) Alternate Work Schedules (AWS) "MAPP Temporarily Removed for Editing and Revision. For additional information, contact the CDER MAPP Team at cdermappteam@fda.hhs.gov".
• 4657.2R (FWAP) Flexiplace and Work at Home "MAPP Temporarily Removed for Editing and Revision. For additional information, contact the CDER MAPP Team at cdermappteam@fda.hhs.gov".
• 4657.3 (PDF - 102KB) Overtime Policy (Original posting 1996; Posted 12/8/2009)
• 4657.5R Advanced Annual and Sick Leave "MAPP Temporarily Removed for Editing and Revision. For additional information, contact the CDER MAPP Team at cdermappteam@fda.hhs.gov".
• 4657.6R Granting Excused Absence(Originator: Division of Management Services, OM) "MAPP Temporarily Removed for Editing and Revision. For additional information, contact the CDER MAPP Team at cdermappteam@fda.hhs.gov".
• 4657.7R Leave and Absence for Hazardous Weather and Other Emergency and Administrative Situations(Revised) (Originator: Division of Management Services, OM; "MAPP Temporarily Removed for Editing and Revision. For additional information, contact the CDER MAPP Team at cdermappteam@fda.hhs.gov".
• 4657.9R (PDF - 73KB)Restoration of Forfeited Annual Leave (Issued 1/13/2006, Posted 1/20/2006)
• 4657.11R Religious Compensatory Time"MAPP Temporarily Removed for Editing and Revision. For additional information, contact the CDER MAPP Team at cdermappteam@fda.hhs.gov".
• 4657.12 Voluntary Leave Transfer Program "MAPP Temporarily Removed for Editing and Revision. For additional information, contact the CDER MAPP Team at cdermappteam@fda.hhs.gov".
• 4658.1 (PDF - 124KB) CDER Full Time Equivalent (FTE) Ceiling and FTE Onboard Tracking and Reporting (Issued and Posted 2/1/2011)
• 4658.2 (PDF - 1,067KB) Time Reporting System (Issued 12/5/2011; Posted 12/6/2011)

Chapter 4700 - Compliance

• 4700.1 (PDF - 22KB) Management of CDER Compliance Coordinating Committee (Issued 3/4/1997, Posted 3/18/1997)
• 4703.1 (PDF - 20KB) Alternate Work Schedules for the Office of Compliance (Originator: Director, Office of Compliance; Issued 11/19/96)
• 4703.2 (PDF - 40KB) Flexible Workplace Arrangements Program for the Office of Compliance (Originator: Director, Office of Compliance; Issued 11/19/96)
• 4723.1 (PDF - 15KB) Standing operating Procedures for NDA/ANDA Field alert Reports (Issued 10/30/1998, Posted 11/02/1998)
• 4730.3 (PDF - 201 KB)Office of Biotechnology Products and Office of Compliance Division of Manufacturing & Product Quality Interactions on BLA Assessments Issued 12/30/2009; Posted 12/30/2009)

Chapter 4800 Office of Counter-Terrorism and Emergency Coordination (OCTEC)

•  4800.1 (PDF - 601KB) Procedures for the Office of Counter-Terrorism and Emergency Coordination Counter - Terrorism Seminar (CT Seminar) ( Issued 12/2/2011; Posted 12/5/2011)

   

Chapter 4900 (Reserved)

 

Chapter 5000 - Pharmaceutical Sciences

• 5000.4recert (PDF - 150KB) CDER Office of Pharmaceutical Science Immediate Office Calendar (Issued 5/8/2003,Posted 5/14/2003; Recertified 7/16/2010)
• 5000.6 (PDF - 39KB) Office of Pharmaceutical Sciences Coordinating Committee (OPS CC) (Issued 6/14/2006, Posted 6/14/2006)
• 5000.7 (PDF - 41KB) Telephone Coverage Policy (Issued and Posted 3/29/2012)
• 5015.3 (PDF - 33KB) Cover Form for the Technical Review of Drug Master Files (Issued 3/23/1998, Posted 4/7/1998)
• 5015.4 (PDF - 66KB) Chemistry Reviews of DMFs for Drug Substances/Intermediates (DSI) (Issued 8/17/98, Posted 10/7/98)
• 5015.5 rev 1 (PDF - 93KB) CMC Reviews of Type III DMF's for Packaging Materials (Issued 8/12/2011, Posted 8/12/2011, Effective 8/12/11)
• 5015-6 (PDF - 20KB) 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 (PDF - 123KB) Environmental Assessments (Issued 3/6/2003, Posted 3/17/2003)
• 5015.8 (PDF - 61KB) Acceptance Criteria for Residual Solvents (Issued 3/10/2009; Posted 3/11/2009)
• 5015.9 (PDF - 119KB) Reporting Format for Nanotechnology-Related Information in CMC Review  (Issued 6/3/2010; Posted 6/3/2010)
• 5016.1 (PDF - 61KB) Applying ICH Q8(R2), Q9, and Q10 Principles to CMC Review (Issued and Posted 2/8/2011)
• 5020.1R (PDF - 25KB) Responding to Telephone Inquiries in the Office of Generic Drugs (Issued 8/1/2006; Posted 8/3/2006)
• 5040.1 (PDF - 145KB) Product Quality Microbiology Information in the Common Technical Document - Quality (CTD-Q) (Issued 5/24/2004)

Chapter 5100 - Clinical Pharmacology

• 5100.3 (PDF - 129KB) OCP Prioritization, Triage, and Review Process for INDs and Pre-INDs (Issued 5/26/2006; Posted 5/30/2006)
• 5100.4 (PDF - 43KB) Scientific Interest Groups: Criteria and Policies. (Issued 4/28/2009; Posted 4/28/2009)
• 5100.5 (PDF - 144KB) An Integrated Genomics, Pharmacometrics, and Clinical Pharmacology Review Process (Issued 6/14/2010; Posted and effective 6/16/2010
• 5120.1R (PDF - 114KB) Office of Clinical Pharmacology Briefing Criteria and Attendance Policies (Issued 11/2/2009, Posted 11/2/2009)

Chapter 5200 - Generic Drugs

• 5200.9 (PDF - 92KB) 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 (PDF - 95KB) Processing of Supplemental Applications Providing for Alternate Stand Alone Packaging Operation Site Changes (Issued 6/9/2005, Posted 6/23/2005)
• 5200.11 (PDF - 36KB) Procedures for Post-Approval Commitment Tracking in the Office of Generic Drugs (Issued 7/13/2007; Posted 7/16/2007) 
• 5210.2 (PDF - 21KB) Reassignment of Bioequivalence Reviews (Revised 5/9/2001, Posted 5/14/2001)
• 5210.4R (PDF - 25KB) Review Responsibility for Bioequivalence Studies with Clinical Endpoints Submitted in an Abbreviated New Drug Application (Issued 12/12/2006, Posted 12/12/2006)
• 5210.5rev (PDF - 125KB) Review of Investigational New Drug Applications (Bio-INDs) by the Office of Generic Drugs (Issued 7/7/2006, Posted 7/7/2006)
• 5210.7 (PDF - 124KB) Inspections of Clinical Facilities and Analytical Laboratories (Issued 12/15/2000, Posted 1/3/2001; Recertified 9/20/2012)
• 5210.8R (PDF - 25KB) Review of Dissolution Data in Supplemental ANDAs (Issued 8/1/2006, Posted 8/3/2006)
• 5221.1R (PDF - 98KB) Requesting Methods Validation for ANDAs (Issued 3/30/2006, Posted 3/30/2006)
• 5223.2 (PDF - 14KB) Scoring Configuration of Generic Drug Products
• 5225.1 (PDF - 22KB) Guidance on the Packaging of Test Batches
• 5240.1 (PDF - 52KB) Requests for Expedited Review of Supplements to Approved ANDAs (Issued and Posted 4/27/2012)
• 5240.3R (PDF - 40KB) Review Order of Original ANDAs, Amendments, and Supplements (Issued and posted 10/18/2006)
• 5240.6 (PDF - 15KB) Telephone Requests by the Division of Bioequivalence (Issued 12/18/2000, Posted 1/3/2001)
• 5240.7 (PDF - 109KB) Telephone Requests by the Divisions of Chemistry (Issued 10/6/2003, Posted 10/8/2003)
• 5240.8 (PDF - 11KB) Handling of Adverse Experience Reports and Other Generic Drug Postmarketing Reports (Issued 11/2/1005, Posted 11/2/2005)
• 5240.9 (PDF - 118KB) Handling and Processing Requests for Global Reviews (Issued 11/29/2004, Posted 12/17/2004)

Chapter 5300 - New Drug Chemistry

• 5310.2 (PDF - 27KB) Drafting, Circulating, and Signing Chemistry, Manufacturing, and Controls Letters (Issued 10/27/1998, Posted 11/02/1998)
• 5310.3 (PDF - 26KB) Requests for Expedited Review of NDA Chemistry Supplements (Issued 6/11/1999, Posted 7/02/1999)
• 5310.4 (PDF - 11KB) Procedures for Evaluating and Handling Field Alert Reports (Posted 11/3/2000)
• 5310.6 (PDF - 141KB) Procedures for Assessing Chemistry, Manufacturing, and Controls Data in NDA Annual Reports (Issued 10/10/2002, Posted 10/18/2002)
• 5310.7R (PDF - 27KB) 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 (PDF - 13KB) Special Government Employees Representing Sponsors Before CDER
• 6002.4 (PDF - 110KB) Government-Issued Nonaccountable Personal Property  (Issued and Posted 12/23/2011) 
• 6003.1 (PDF - 78KB) Drug Shortage Management Issued (9/26/2006, Posted 9/28/2006)
• 6004.2Rev 1 (PDF - 310KB) Procedures for Completing and Processing the Form "Annual Status Report Review Form: PMR and PMC Summary" (Issued 10/26/2011, Posted 10/26/2011)
• 6007.1 (PDF - 126KB) Review of Botanical Drug Products (Issued 6/7/2004, Posted 6/9/2004; recertified 5/2/2012)
• 6010.2R (PDF - 251KB) Responsibilities for Tracking and Communicating the Status of Postmarketing Requirements and Commitments
• 6010.3R (PDF - 43KB) Good Review Practice: Clinical Review Template (Issued 12/14/2010; Posted 12/14/2010)
  • 6010.3R (PDF - 280KB) Attachment A: Annotated Clinical Review Template (Issued 12/14/2010; Posted 12/14/2010)
  • 6013.3R (PDF - 816KB) Attachment B: Clinical Safety Review of an NDA or BLA (Issued 12/14/2010; Posted 12/14/2010)
• 6010.4 (PDF - 357KB)  Good Review Practice: Statistical Review Template (Issued and posted 7/31/2012)
• 6010.5 (PDF - 108KB) NDAs: Filing Review Issues (Issued 5/8/2003, Posted 5/14/2003)
• 6010.6 (PDF -120KB) The Use of Clinical Source Data in the Review of Marketing Applications (Issued 10/18/2010; Posted 10/18/2010)
• 6010.7 (PDF - 36KB) Clinical Hold/Refusal-to-File Committee (Issued 1/9/2008; Posted 1/9/2008)
• 6010.8 (PDF - 118KB) NDAs and BLAs: Communication to Applicants of Planned Review Timelines.
• 6010.9 (PDF - 209KB) Procedures and Responsibilities for Developing Postmarketing Requirements and Commitments (Issued 3/10/2009; Posted 3/11/2009)
   
• 6020.1 (PDF - 11KB) Extraneous References in Product Labeling: Exclusion of American Hospital Formulary Service (AHFS) Pharmacologic-Therapeutic Classifications
• 6020.2R (PDF - 24KB) Applications for Parenteral Products in Plastic Immediate Containters (Issued 4/25/07 Posted 5/4/2007)
• 6020.3R (PDF - 75KB) Review Classification Policy: Priority (P) and Standard (S) (Revised 7/18/2007; Posted 7/18/2007; Recertified 2/3/12)
• 6020.4 Rev1 (PDF - 65KB) Classifying Resubmissions of Original NDAs, BLAs, and Efficiacy Supplements in Response to Action Letters (Issued 3/15/2012, Posted 3/16/2012)
• 6020.5R (PDF - 107KB) Good Review Practice: OND Review Management of INDs and NDAs for Nonprescription Drug Products (Issued 7/13/2007, Posted 7/16/2007)
• 6020.7 (PDF - 106KB) NDAs: Foreign Language Labeling (Issued 7/9/004, Posted 7/12/2004)
• 6020.8 (PDF - 112KB) Action Packages for NDAs and Efficacy Supplements (Issued 11/13/2002, Posted 12/11/2002)
• 6020.10 (PDF - 114KB) NDAs: "Dear Health Care Professional" Letters (Issued 7/2/2003, Posted 10/2/2003)
• 6020.13 (PDF - 43KB) Clinical Review of Drugs to Reduce the Risk of Cancer (Issued 12/13/2005, Posted 12/15/2005)
• 6020.14 (PDF - 136KB) Interdisciplinary Review Team for QT Studies (Issued 10/18/2007; Posted 10/19/2007; Recertified 2/3/12)
• 6025.1 (PDF - 69KB) Good Review Practices (Issued 9/5/2006; Recertified 2/3/12; Posted 2/28/12)
• 6025.3 (PDF - 39KB) Good Review Practice: Consultative Review of Drugs Regulated Within OND. (Issued 1/12/2007; Posted 1/16/2007)
• 6030.1 (PDF - 32KB) IND Process and Review Procedures (Issued 5/1/1998, Posted 5/14/1998)
• 6030.2 (PDF - 122KB) INDs: Review of Informed Consent Documents (Issued 11/13/2002, Posted 12/11/2002)
• 6030.4 (PDF - 19KB) INDs: Screening INDs (Issued 5/9/2001, Posted 5/14/2001)
• 6030.6 (PDF - 164KB) INDs: Processing Treatment INDs and Treatment Protocols (Issued and Posted and 12/8/2011)
• 6030.8 (PDF - 141KB) INDs: Exception from Informed Consent Requirements for Emergency Research (Issued 2/4/2003, Posted 3/17/2003)
• 6050.1Rev.1 (PDF - 76KB) Refusal to Accept Application for Filing From Applicants in Arrears (Issued 8/14/2007; Posted 8/21/2007; Recertified 4/18/2012)

 

Chapter 6100 - Office of Drug Evaluation I

 

Chapter 6200 - Office of Drug Evaluation II

 

Chapter 6300 - Office of Drug Evaluation III

 

Chapter 6400 - Office of Drug Evaluation IV

 

Chapter 6500 - Office of Drug Evaluation V

 

Chapter 6600 - Epidemiology and Biostatistics

• 6610.1 (PDF - 17KB) Statistical Policy Coordinating Committee (Issued 7/28/1999, Posted 7/28/1999)
• 6610.2 (PDF - 124KB) Responsibilities and Procedures for Statistical Review and Evaluation of Animal Carcinogenicity Studies (Issued 11/30/2004, Posted 12/17/2004)

 Chapter 6700 - Office of Surveillance and Epidemiology

• 6700.1 (PDF - 46KB) 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 (PDF - 146KB) Standards for Data Management and Analytic Processes in the Office of Surveillance and Epidemiology (OSE) (Issued 3/3/2008; Posted 3/4/2008)
• 6700.5 (PDF - 41KB) Responding to Requests For Waivers of Postmarketing Safety Reporting Requirements under 21 CFR §§ 314.80 (NDAs), 314.98 (ANDAs), and 600.80 (BLAs) (Issued and Posted 3/5/2012)
• 6700.9 (PDF - 121KB) FDA Posting of Potential Signals of Serious Risks Identified by the Adverse Event Reporting System (Issued and  Posted 3/29/2011; updated 12/13/2011)
• 6720.2 (PDF - 209KB) Procedures for Handling Requests for Proprietary Name Review (Issued 9/16/2009; Posted 9/17/2009)
• 6730.1 (PDF - 64KB) Use of Review Templates in the Office of Surveillance and Epidemiology (Issued 1/24/2012; Posted 1/24/2012; Effective 1/25/2012)
   

Chapter 7000 - Discipline Specific

 

Chapter 7100 - Biopharmaceutics

 

Chapter 7200 - Chemistry

• 7211.1 (PDF - 11KB) Drug Application Approval 501(b) Policy

Chapter 7300 - Medical/Statistical

 

Chapter 7400 - Pharmacology and Toxicology

• 7400.1R2 (PDF - 119KB) Management of CDER Pharmacology/Toxicology Coordinating Committee and Its Associated Subcommittees and Working Groups (Issued 6/1/2011; Posted 6/1/2011).
• 7400.4 (PDF - 109KB) 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)
• 7412.1 (PDF - 28KB) Management of CDER Carcinogenicity Assessment Committee (CAC) and Executive CAC
• 7412.2 (PDF - 11KB) 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 (PDF - 79KB) Office of New Drugs Regulatory Project Management Coordinating Committee (Issued 5/15/2008, Posted 5/15/2008)
• 7500.2 Rev1 (PDF - 59KB) Regulatory Project Management Site Tours and Regulatory Interactions Program (Issued 3/26/2012, Posted 3/26/2012)
• 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

• 7600.3 (PDF - 276KB) Maintaining CDER'S Electronic Submissions Docket (Issued 10/15/1997, Posted 11/14/1997)
• 7600.6 (PDF - 19KB) Requesting and Accepting Non-Archivable Records in Electronic Format for New Drug Applications (Issued 11/12/1999, Posted 11/17/1999)
• 7600.8 (PDF - 221KB) CDER Informatics Governance Process (Issued 5/24/2011, Posted 5/24/2011)
• 7610.2 (PDF - 11KB) Use of Government Electronic Equipment and Systems (Issued 5/8/1998, Posted 5/14/1998)

Chapter 7700 - Office of Translational Sciences

• 7700.1 (PDF - 33KB) Management of the Regulatory Science and Review Enhancement Committee (Issued 4/8/2008 Posted 4/8/2008)
• 7700.2 (PDF - 199KB) Review and Conduct of Human Subject Research (Issued 5/18/2009; Posted 5/19/2009)
• 7700.3 (PDF - 103KB) CDER Science Projects Database (Issued 5/10/2010; Posted 5/11/2010)

Chapter 7800 - Administrative Management

• 7800.1R (PDF - 35KB) Administrative Management Coordinating Committee (Issued 2/22/2007, Posted 2/22/2007)