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Agency Program Directives, Volume IV (4000-9100)

NUMBER SUBJECT
4000 - 4999 PREMARKET REVIEW
4100 Combination Products
4101 Intercenter Consultative/Collaborative Review Process
5000 - 5999 LABORATORY PROGRAMS (ANALYTICAL AND METHODOLOGY)
6000 - 6999 INSPECTION
7000 - 7999 COMPLIANCE
7100 Compliance Policy Manual (CPG)
7300 Compliance Program Guidance Manual (CPGM)
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
9002.1 FDA's Response to Cargo Thefts
9003.1 Policy for Responding to Allegations of Research Misconduct
9004.1 Interim Framework for Requesting Records In Advance of Or In Lieu of a Drug Inspection In the Event of a Public Health Incident Related to Drugs
9010 Dispute Resolution
9010.1 Scientific Dispute Resolution at FDA
9010.2 Cross-Center Dispute Resolution at FDA
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

 

 
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