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        Center for Drug Evaluation and Research | CDER

CDER Manual of Policies & Procedures | MAPP Home
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          Center for Drug Evaluation and Research | CDER
          CDER Manual of Policies & Procedures | MAPPCenter for Drug Evaluation and Research | CDER CDER Manual of Policies & Procedures | MAPP
  	
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    PrintCDER'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.  A MAPP may be removed from this FDA.gov page while it is being evaluated and updated. 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).

*Please note that due to a CDER-wide initiative to update MAPPs, MAPPs may be removed for revision, recertification, or cancellation. Thank you for your patience.*


MAPP #
			Office
			Title
			Category
			Date Posted5017.8
			Office of Pharmaceutical Quality
			Responsibilities for the Assessment of In Vitro Testing for Oral Drug Products Administered Via Enteral Feeding Tube
			Regulatory Review and Scientific Policies
			8/31/20235016.8 Rev. 1
			Office of Pharmaceutical Quality
			Using Four-Part Harmony in Quality-Related Assessment Communications
			Regulatory Review and Scientific Policies
			8/25/20234301.1 Rev. 3
			Office of Medical Policy
			CDER Medical Policy Council
			Leadership and Mission
			2/23/20215021.5 Rev. 1
			Office of Pharmaceutical Quality
			Assessment of Facility-Based Deficiency Major-to-Minor Reclassification Requests
			Regulatory Review and Scientific Policies
			12/21/20236021.1
			Office of New Drugs
			NDAs/BLAs: Financial Disclosure
			New Drug Review
			6/21/20174100.2
			Office of Translational Sciences
			CDER Staff Participation in Public Private Partnerships and Consortia

			Request for CDER Participation in a Public Private Partnership or Consortium Activity Form
				CDER Public-Private Partnership (PPP) Liaison Initiation Form
				CDER Public Private Partnership (PPP) Liaison Annual Update Form
			Regulatory Review and Scientific Policies
			4/21/20235100.3
			Office of Clinical Pharmacology
			OCP Prioritization, Triage, and Review Process for INDs and Pre-INDs
			Regulatory Review and Scientific Policies
			3/30/20234651.3
			Office of Management
			PHS Commissioned Corps Awards
			Staff Resources and Services
			2/27/20235015.13
			Office of Pharmaceutical Quality
			Quality Assessment for Products in Expedited Programs
			Regulatory Review and Scientific Policies
			11/1/20225022.0
			Office of Pharmaceutical Quality
			Roles and Responsibilities of FDA Liaisons to Standards Development Organizations
			Regulatory Review and Scientific Policies
			12/7/20225015.12
			Office of Pharmaceutical Quality
			Process for Evaluating Emerging Technologies Related to Quality
			Regulatory Review and Scientific Policies
			11/29/20225100.6
			Office of Translational Science
			Policy and Procedures for Creating an Interest Group in the Office of Biostatistics
			Regulatory Review and Innovation
			6/23/20225019.2
			Office of Pharmaceutical Quality
			Assessment of the Appropriate Net Container Content for Injectable Drug and Biological Products
			Regulatory Review and Scientific Policies
			6/13/20225223.6
			Office of Generic Drugs
			Assessment of the User Interface of a Drug-Device Combination Product Submitted in a Pre-ANDA Communication or an ANDA
			Generic Drug Review
			6/7/20225220.3
			Office of Generic Drugs
			Communicating Certain Deficiencies Identified During Filing Review of ANDAs
			Generic Drug Review
			9/28/20175240.10
			Office of Generic Drugs
			Classifying Approved New Drug Products and Drug-device Combination Products as Complex Products for Generic Drug Development Purposes
			Generic Drug Review
			4/13/20224151.8 Rev. 1
			Office of Executive Program
			Equal Voice: Collaboration and Regulatory and Policy Decision-Making in CDER
			Staff Resources & Services
			4/12/20225019.1 Rev.1
			Office of Pharmaceutical Quality
			Allowable Excess Volume/Content in Injectable Drug and Biological Products
			Regulatory Review and Scientific Policies
			1/29/20226050.2 Rev. 1
			Office of Management
			Effect of Failure to Pay BsUFA Fees
			Staff Resources and Services
			10/05/20235021.1 Rev.1
			Office of Pharmaceutical Quality
			Naming of Drug Products Containing Salt Drug Substances
			Regulatory Review and Scientific Policies
			12/2/20225021.2
			Office of Pharmaceutical Quality
			Evaluating Color Additives and Flavors Intended for Oral Drug Products Submitted or Referenced in INDs and NDAs
			Regulatory Review and Scientific Policies
			6/3/20214657.0 Rev. 1
			Office of Management
			CDER’s Time, Attendance, and Leave Recording Policy
			Staff Resources and Services
			5/19/20217600.10
			Office of Strategic Programs
			CDER Master Data Management
			Information Technology
			4/15/20227610.8
			Office of Strategic Programs
			Electronic and Digital Signatures for Records Management
			Drug
			8/12/20226720.4
			Office of Surveillance and Epidemiology
			Procedures for Sharing Non-public Information on Pending Proposed Proprietary Names
			Drug Safety
			9/21/20166030.3
			Office of New Drugs
			Emergency Investigational New Drug Application Process During and After Normal Business Hours
			New Drug Review
			9/5/20185241.3 Rev.1
			Office of Generic Drugs and Office of Pharmaceutical Quality
			Good Abbreviated New Drug Application Assessment Practices
			Generic Drug Review
			10/6/20235240.3 Rev.6
			Office of Generic Drugs
			Prioritization of the Review of Original ANDAs, Amendments, and Supplements
			Generic Drug Review
			12/14/20225231.1
			Office of Compliance
			CDER Barcode Inquiries
			Public Outreach
			11/15/20185220.5 Rev.2
			Office of Generic Drugs
			Issuance of Information Requests and/or Discipline Review Letters for ANDAs under the Reauthorization of GDUFA
			Generic Drug Review
			10/5/20225220.1
			Office of Generic Drugs
			Receiving and Processing a Request for Voluntary Withdrawal of an Approved ANDA
			Generic Drug Review
			1/25/20235200.14 Rev.1
			Office of Generic Drugs
			Filing Review of Abbreviated New Drug Applications
			Generic Drug Review
			10/2/20235200.12
			Office of Generic Drugs and Office of Pharmaceutical Quality
			Communicating Abbreviated New Drug Application Review Status Updates with Industry
			Generic Drug Review and Regulatory Review and Scientific Policies
			10/5/20225200.7 Rev.1
			Office of Generic Drugs
			ANDA Amendments and Supplements Reviewed by the Division of Filing Review
			Generic Drug Review
			4/17/20205016.6
			Office of Pharmaceutical Quality
			Change in Hard Gelatin Capsule Supplier
			Regulatory Review and Scientific Policies
			2/21/20235014.1 Rev.1
			Office of Pharmaceutical Quality
			Understanding CDER's Risk-Based Site Selection Model
			Regulatory Review and Scientific Policies
			6/26/20235001.1
			Office of Pharmaceutical Quality
			Drug Product Distribution After a Complete Response Action to a Changes Being Effected Supplement
			Regulatory Review and Scientific Policies
			11/23/20224410.1 Rev. 1.
			Office of Communications
			FDA Pharmacy Student Experiential Program
			Public Outreach
			8/28/20195017.2 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
			5/20/20205242.1
			Office of Generic Drugs
			Transfer of Ownership
			Generic Drug Review
			8/26/20206701.4
			Office of Surveillance and Epidemiology
			Notifying Applicants of Sentinel Analyses and Results
			Drug Review
			8/17/20206702.2
			Office of Surveillance and Epidemiology
			Determination of the Need for and Review of a New REMS
			Drug Review
			6/18/20205220.2
			Office of Generic Drugs
			Conversion of ANDA Approval to Tentative Approval Because of Court Order
			Generic Drug Review
			6/11/20204121.3
			Office of the Center Director
			Collaborative Identification, Evaluation, and Resolution of a Newly Identified Safety Signal (NISS)
			Leadership and Mission
			4/30/20206702.1
			Office of Surveillance and Epidemiology
			Risk Evaluation and Mitigation Strategy (REMS) Assessment
			Drug Safety
			12/18/20196701.1
			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
			9/18/20195220.8
			Office of Generic Drugs
			Evaluating Requests for and Conducting Product Development and Pre-Submission Pre-ANDA Meetings
			Generic Drug Review
			10/5/20224191.1
			Office of New Drugs
			Risk Evaluation and Mitigation Strategies Modifications and Revisions
			New Drug Review
			6/29/20206004.3
			Office of New Drugs
			Safety Labeling Changes Under Section 505(o)(4) of the FD&C Act
			New Drug Review
			7/09/20195017.4
			Office of Pharmaceutical Quality
			Quality Center for Drug Evaluation and Research Biopharmaceutics Council
			Regulatory Review and Scientific Policies
			4/24/20196720.5
			Office of Surveillance and Epidemiology
			Procedures for Handling Requests for Nonproprietary Name Suffix Review for Biological Products Newly Licensed Under Section 351of the PHS Act
			Drug Safety
			3/7/20196701.3 Rev.1
			Office of Surveillance and Epidemiology
			Development of a Single, Shared System (SSS) Risk Evaluation and Mitigation Strategy (REMS) or a Separate REMS with Elements to Assure Safe Use (ETASU): Responsibilities and Procedures
			Drug Safety
			10/28/20204000.1 Rev.6
			Office of Management
			Developing and Issuing MAPPs for CDER
			Staff Resources and Services
			9/9/20214000.4 Rev 1
			Office of Translational Sciences
			Clinical Pharmacology and Biopharmaceutics NDA Review Template
			Regulatory Review and Innovation
			1/30/20234112.2 Rev.1
			Office of Executive Programs
			Sharing Nonpublic Information with Federal Government Officials.
			Regulatory Policy and Information Disclosure
			10/27/20224160.2 Rev.1
			Office of the Center Director
			Prioritization of Requests for Training and Visits by Foreign Regulatory Agencies and International Regulatory Organizations
			Leadership and Mission
			11/9/20227400.13
			Office of New Drugs
			Determining the Established Pharmacologic Class for Use in the Highlights of Prescribing Information
			New Drug Review
			7/25/20184200.1 Rev.1
			Office of the Center Director
			Procedures for Review of Protocols Referred By DEA That use Schedule I controlled Substances and Drugs
			Leadership and Mission
			11/12/20204200.2 Rev. 1
			Office of the Center Director
			Forecasting Schedule I and II Substance and Drug Needs
			Leadership and Mission
			12/21/20204200.3 Rev. 2
			Office of the Center Director
			Consulting the Controlled Substance Staff on Abuse Liability, Drug Dependence, Risk Management, and Drug Scheduling
			Drug Safety
			10/26/20224601.3 Rev.2
			Office of Management
			Children in the Workplace
			Staff Resources and Services
			1/22/20214516.1 Rev 1
			Office of Communications
			Criteria for Developing and Publishing Digital Content on the CDER External Web Site
			Public Outreach
			3/12/20204512.2 Rev.2
			Office of Strategic Programs
			Conducting Effective Meetings in CDER: Remote Access Considerations
			Information Technology
			12/8/20214510.2 Rev.2
			Office of Regulatory Policy
			CDER Clearance of FDA Related Articles,Speeches and Other Publications
			Regulatory Policy and Information Disclosure
			9/17/20204510.1 Rev.2
			Office of Communications
			CDER Process for Authorizing Staff to Participate in External Events
			Public Outreach
			11/25/20224520.1 Rev. 2
			Office of Communications
			Communicating Drug Approval Information
			Public Outreach
			11/10/20225017.1Rev.1
			Office of Pharmaceutical Quality
			Office of Biotechnology Products and Office of Pharmaceutical Manufacturing Assessment, Interactions on BLA Assessments
			Regulatory Review and Scientific Policies
			12/2/20225015.7 Rev.1
			Office of Pharmaceutical Quality
			Environmental Assessments
			Regulatory Review and Scientific Policies
			11/23/20225015.6 Rev.1
			Office of Pharmaceutical Quality
			Review of Grouped Product Quality Supplements
			Regulatory Review and Scientific Policies
			12/9/20225015.5 Rev.1
			Office of Pharmaceutical Quality
			CMC Reviews of Type III DMF's for Packaging Materials
			Regulatory Review and Scientific Policies
			12/9/20225015.8
			Office of Pharmaceutical Quality
			Acceptance Criteria for Residual Solvents
			Regulatory Review and Scientific Policies
			12/1/20225016.1
			Office of Pharmaceutical Quality
			Applying ICH Q8(R2), Q9, and Q10 Principles to CMC Review
			Regulatory Review and Scientific Policies
			5/17/20165040.1
			Office of Pharmaceutical Quality
			Product Quality Microbiology Information in the Common Technical Document - Quality (CTD-Q)
			Regulatory Review and Scientific Policies
			12/7/20225100.4 Rev.1
			Office of Translational Sciences
			Scientific Interest Groups: Criteria and Policies.
			Regulatory Review and Innovation
			9/1/20215210.4 Rev 3
			Office of Generic Drugs
			Assessment of Bioequivalence Studies with Clinical Endpoints in ANDAs
			Generic Drug Review
			4/28/20235210.5 Rev.3
			Office of Generic Drugs
			Review of Investigational New Drug Applications (Bio-INDs) by the Office of Generic Drugs
			Generic Drug Review
			4/14/20225230.3 Rev.2
			Office of Generic Drugs
			Generic Drug Labeling Revisions Covered Under Section 505(j)(10) of the Federal Food, Drug, and Cosmetic Act
			Generic Drug Review
			12/13/20236020.4 Rev.2
			Office of New Drugs
			Classifying Resubmissions of Original NDAs, BLAs, and Efficiacy Supplements in Response to Action Letters
			New Drug Review
			2/26/20156020.2 Rev.1
			Office of New Drugs
			Applications for Parenteral Products in Plastic Immediate Containers
			New Drug Review
			12/19/20236010.9
			Office of New Drugs
			Procedures and Responsibilities for Developing Postmarketing Requirements and Commitments
			New Drug Review
			3/9/20096010.8 Rev.1
			Office of New Drugs
			NDAs and BLAs: Communication to Applicants of Planned Review Timelines
			New Drug Review
			8/25/20146010.6
			Office of New Drugs
			The Use of Clinical Source Data in the Review of Marketing Applications
			New Drug Review
			10/18/20106010.5
			Office of New Drugs
			NDAs: Filing Review Issues
			New Drug Review
			3/27/20186010.2
			Office of New Drugs
			Responsibilities for Tracking and Communicating the Status of Postmarketing Requirements and Commitments
			New Drug Review
			7/28/20095210.9 Rev.1
			Office of Pharmaceutical Quality
			Review of Botanical Drug Products
			Regulatory Review and Scientific Policies
			11/8/20166004.2 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
			9/27/20174190.1 Rev.3
			Office of the Center Director
			Drug Shortage Management
			Medical Policy
			11/30/20186001.1 Rev. 1
			Office of Executive Programs
			Special Government Employees Representing Sponsors Before CDER
			Executive Secretariat
			9/16/20225310.7 Rev.1
			Office of Pharmaceutical Quality
			Acceptability of Standards From Alternative Compendia (BP/EP/JP)
			Regulatory Review and Scientific Policies
			12/7/20225310.3 Rev.2
			Office of Pharmaceutical Quality
			Requests for Expedited Review of New Drug Application and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and Controls Changes
			Regulatory Review and Scientific Policies
			4/08/20216030.1 Rev.3
			Office of New Drugs
			IND Clinical Holds
			New Drug Review
			2/20/20186020.8 Rev 1
			Office of New Drugs
			NDAs/BLAs/Efficacy Supplements: Action Packages and Taking Regulatory Actions
			New Drug Review
			6/14/20166020.5 Rev. 2
			Office of New Drugs
			Good Review Practice: OND Review Management of INDs and NDAs for Nonprescription Drug Products
			New Drug Review
			6/25/20187600.6 Rev. 2
			Office of Strategic Programs
			Requesting and Accepting Non-Archivable Records in Electronic Format for New Drug Applications
			Information Technology
			4/24/20237500.1 Rev. 2
			Office of New Drugs
			Regulatory Project Management Coordinating Committee
			New Drug Review
			9/5/20187400.4 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
			2/25/20157400.1 Rev.2
			Office of New Drugs
			Management of CDER Pharmacology/Toxicology Coordinating Committee and Its Associated Subcommittees and Working Groups
			New Drug Review
			5/17/20166720.2 Rev.1
			Office of Surveillance and Epidemiology
			Procedures for Handling Requests for Proprietary Name Review
			Drug Safety
			1/8/20166700.5
			Office of Surveillance and Epidemiology
			Responding to Requests For Waivers of Postmarketing Safety Reporting Requirements under 21 CFR Â§Â§ 314.80 (NDAs), 314.98 (ANDAs), and 600.80 (BLAs)
			Drug Safety
			7/25/20226700.9
			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
			9/10/20196610.1 Rev. 2
			Office of Translational Sciences and Biostatistics
			Statistical Policy Council
			Regulatory Review and Innovation
			6/1/20216050.1 Rev. 2
			Office of Management
			Effect of Failure to Pay PDUFA Fees
			Staff Resources and Services
			12/01/20216030.9
			Office of New Drugs
			Good Review Practice: Good Review Management Principles and Practices for Effective IND Development and Review
			New Drug Review
			4/29/20136030.8 Rev.1
			Office of New Drugs
			INDs: Exception from Informed Consent Requirements for Emergency Research
			New Drug Review
			11/17/20146030.6
			Office of New Drugs
			INDs: Processing Treatment INDs and Treatment Protocols
			New Drug Review
			12/9/20116030.2 Rev.1
			Office of New Drugs
			INDs: Review of Informed Consent Documents
			New Drug Review
			5/2/20146020.3 Rev.2
			Office of New Drugs
			Review Designation Policy: Priority (P) and Standard (S)
			New Drug Review
			6/25/20135240.5 Rev.3
			Office of Generic Drugs
			ANDA Suitability Petitions
			Generic Drug Review
			9/29/20237620.6
			Office of the Center Director
			Preparation of Topics and Nomination of Experts For Development and Harmonization of International Scientific and Technical Guidelines
			Information Technology
			9/25/20137610.6 Rev.1
			Office of Strategic Programs
			CDER Electronic Application Forms Oversight
			Information Technology
			10/7/20226025.4
			Office of New Drugs
			Good Review Practice: Refuse to File
			New Drug Review
			9/5/20186025.2
			Office of New Drugs
			Good Review Practice: Clinical Review of Investigational New Drug Applications
			New Drug Review
			3/5/20187412.1 Rev.2
			Office of New Drugs
			Management of CDER Executive Carcinogenicity Assessment Committee and Communication of Committee Proceedings
			New Drug Review
			6/8/20187412.2 Rev.1
			Office of New Drugs
			Management of CDER Carcinogenicity Assessment Committee and Communication of Committee Proceedings
			New Drug Review
			6/7/20184642.3
			Office of Management
			Student Volunteer Employment Program (SVEP)
			Staff Resources and Services
			10/5/20236025.6
			Office of New Drugs
			Good Review Practice: Management of Breakthrough Therapy-Designated Drugs and Biologics
			New Drug Review
			7/29/20145016.3
			Rev. 1
			Office of Pharmaceutical Quality
			Responsibility for the Quality Assessment of Products Containing Peptide or Protein Drug Substances
			Regulatory Review and Scientific Policies
			6/21/20237600.11
			Office of Strategic Programs
			CDER Electronic Record Keeping System
			Information Technology
			9/29/20144100.1 Rev.2
			Office of Management
			CDER Co-Sponsorship Agreements for Events
			Staff Resources and Services
			6/21/20227700.5 Rev.1
			Office of Translational Sciences
			Critical Path Innovation Meetings Policy and Procedures
			Regulatory Review and Innovation
			4/14/20214001.1
			Office of Management
			Developing, Issuing and Maintaining Standard Operating Procedures for CDER
			Staff Resources and Services
			2/1/20236025.7
			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
			3/9/20154651.4 Rev.1
			Office of Management
			CDER Incentive Awards Program (Cash and Time-off)
			Staff Resources and Services
			7/16/20204800.2 Rev.1
			Office of the Center Director
			Continuity of Operations (COOP)
			Leadership and Mission
			7/21/20217610.7 Rev.1
			Office of Strategic Programs
			CDER Data Standards Program
			Information Technology
			8/31/20215241.2 Rev. 1
			Office of Generic Drugs
			Consolidation of ANDAs by the Office of Generic Drugs
			Generic Drug Review
			8/19/20206001.2 Rev.1
			Office of Communications
			CDER Network Of Experts
			Leadership and Mission
			10/12/20215018.2
			Office of Pharmaceutical Quality
			NDA Classification Codes
			Regulatory Review and Scientific Policies
			12/6/2022

                                                                                  Content current as of:
      01/24/2024
                  
                   
Regulated Product(s)
		 DrugsCDER Manual of Policies & Procedures | MAPP
 
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