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Inspections, Compliance, Enforcement, and Criminal Investigations
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Resources for You
- Application Integrity Policy
- Bioresearch Monitoring
- Disqualified/Restricted/ Restrictions Removed/ Assurance Lists for Clinical Investigators
- Current Good Manufacturing Practices (cGMP) for Drugs: Reports, Guidances and Additional Information
- FDA Debarment List
- Public Health Service Administrative Actions Listing
- ORA FOIA Electronic Reading Room
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Compliance Manuals
We have recently redesigned the FDA Web Site. As a result, some Web links (URLs) embedded within guidance documents are no longer valid. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to Contact FDA.
This page provides links to documents, lists, policies, programs, and statements relating to Compliance References used by FDA personnel:
Revisions
Revisions, Drafts, and Updates to ORA compliance references
Manuals
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- Federal Food, Drug, and Cosmetic Act, FDA Regulations and Additional laws enforced by the FDA Code of Federal Regulations - Title 21
- Compliance Program Guidance Manual (CPGM)
Compliance programs and program circulars (program plans and instructions) directed to field personnel for project implementation. - Compliance Policy Guides (CPG)
Contains FDA compliance policy and regulatory action guidance for FDA staff. - Regulatory Procedures Manual (RPM)
Contains FDA regulatory procedures for use by FDA personnel. A reference document for enforcement procedures and practices.
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