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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 (Drug Product Applications) Public Health Service Administrative Actions Listing ORA FOIA Electronic Reading Room
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Compliance Manuals
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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. - Staff Manual Guides (SMG)
The Agency directives that document organizations and functions, delegations of authority, general administrative operations, and programs of the FDA.
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