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Agency Program Directives, Volume IV (4000-9100)

NUMBERSUBJECT
4000 - 4999PREMARKET REVIEW
4100Combination Products
4101Intercenter Consultative/Collaborative Review Process
5000 - 5999LABORATORY PROGRAMS (ANALYTICAL AND METHODOLOGY)
6000 - 6999INSPECTION
7000 - 7999COMPLIANCE
7100Compliance Policy Manual (CPG)
7300Compliance Program Guidance Manual (CPGM)
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 Restricited 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
8000 - 8999FDA-STATE RELATIONS
9000GENERAL OR MULTIDISCIPLINE
9001.1Scientific Integrity at FDA
9002.1FDA's Response to Cargo Thefts
9003.1Policy for Responding to Allegations of Research Misconduct
9010Dispute Resolution
9010.1Scientific Dispute Resolution at FDA
9010.2Cross-Center Dispute Resolution at FDA
9100Common Standards
9100.1Development and Use of Standards
9110Business 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