This page provides links to documents, lists, policies, programs, and statements relating to Compliance References used by FDA personnel:
The Compliance Program Guidance Manuals (CPGM) provide instructions to FDA personnel for conducting activities to evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act and other laws administered by FDA. Compliance Programs are made available to the public under the Freedom of Information Act. (See FDA Freedom of Information Act Handbook for Requesting Information and Records from FDA).
Compliance Programs do not create or confer any rights for or on any person and do not bind FDA or the public. An alternative approach may be used as long as the approach satisfies the requirements of the applicable statutes and regulations.
Compliance Policy Guides (CPG)
Compliance Policy Guides (CPG) contains FDA compliance policy and regulatory action guidance for FDA staff.
Regulatory Procedures Manual (RPM)
The Regulatory Procedures Manual is a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used in processing domestic and import regulatory and enforcement matters. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.
- Federal Food, Drug, and Cosmetic Act (FD∓C Act)
- Compliance Program Guidance Manual (CPGM)
- FDA Compliance Policy Guides (CPG)
- Regulatory Procedures Manual (RPM)
- Application Integrity Policy
- FDA Bioresearch Monitoring Information
- FDA Debarment List (Drug Product Applications)
- Clinical Investigators - Disqualification Proceedings
- ORA FOIA Electronic Reading Room