FDA Compliance Manuals

Compliance Manuals | Regulatory Doctor

Revisions

Revisions, Drafts, and Updates to ORA compliance references

Manuals

• 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 (program plans and instructions) directed to field personnel.
• 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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