U.S. flag An official website of the United States government
  1. Home
  2. About FDA
  3. Reports, Manuals, & Forms
  4. Staff Manual Guides
  5. Agency Program Directives, Volume IV (4000 - 9100)
  1. Reports, Manuals, & Forms

Agency Program Directives, Volume IV (4000 - 9100)

Agency Program Directives, Volume IV (4000 - 9100)

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