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  5. Agency Program Directives, Volume IV (4000 - 9100)
  1. Staff Manual Guides

Agency Program Directives, Volume IV (4000 - 9100)

NUMBERSUBJECT
4000 - 4999PREMARKET REVIEW
4100Combination Products
4101Inter-Center Consult Request Process
4102Intercenter Coordination of Regulatory Activities for Genetically Engineered Animals and Their Expression Products
4103Expectations and Procedures for Engagement Among Medical Product Centers and Office of Combination Products on Regulations and Guidance Pertaining to Combination Products
4104Inter-center Consults for Review of Human Factors Information
5000 - 5999LABORATORY PROGRAMS (ANALYTICAL AND METHODOLOGY)
6000 - 6999INSPECTION
7000 - 7999COMPLIANCE
7100Compliance Policy Guides (CPG) manual
7100.1Management of the FDA Compliance Policy Guides manual
7300Compliance Program Manual (CPM)
7300.1Management of the Compliance Program Manual
7711Disqualification of a Clinical Investigator: The Hearing Process
7711.1Maintaining and Controlling Part 16 Regulatory Hearing Administrative Records for Investigator Disqualification Matters
7712Debarment Proceedings
7713Clinical Investigator Restricted Agreement Compliance and Change in Status from "Restricted" to "Restrictions Removed"
7714Disqualification of an Institutional Review Board (IRB), Parent Institution, or Component of Parent Institution
7715FDA Consideration of Reinstatement Requests from Disqualified Clinical Investigators
8000 - 8999FDA-STATE RELATIONS
8070Contract Management
8076FDA State Contract Audit Program
9000GENERAL OR MULTIDISCIPLINE
9001.1Scientific Integrity at FDA
9001.3Research Involving Human Fetal Tissue
9001.4Human Subjects Research Conducted or Supported by the FDA
9002.1FDA's Response to Cargo Thefts
9003.1Policy for Responding to Allegations of Research Misconduct
9004.1Policy and Procedures for Requesting Records in Advance of or In Lieu of a Drug Inspection
9005.1Scientific Collections Management and Access Policy
9006Public Engagement Staff FDA Patient Listening Sessions
9010Decision and Dispute Resolution
9010.1Scientific Dispute Resolution at FDA
9010.2Cross-Center Dispute Resolution at FDA
9010.3Authorship Dispute Resolution at FDA
9010.5Requests for Review under 21 CFR Section 10.75 Submitted to the Office of the Commissioner by Interested Persons Outside the Agency
9100Common Standards
9100.1Development and Use of Standards
9110 - 9120Business Practices and Agreements
9110Enhanced Communications with OCI and Improved Alignment of Criminal/Regulatory Priorities
9111Sharing of Information Related to Criminal Violations
9120Intercenter Coordination of Cross-Labeling Activities for Approved Drugs/Biologics and In Vitro Diagnostics
9121Framework for Mutual Recognition Agreements and Arrangements Relating to Drugs

 

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