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  1. Compliance Manuals

Manual of Compliance Policy Guides

Foreword

Compliance Policy Guides (CPGs) are intended to advise Food and Drug Administration (FDA) staff as to the Agency's strategy when assessing and enforcing industry compliance.

They typically establish FDA policy and interpretation where there is a need for clarification or to address other issues not covered by existing FDA laws, regulations, or guidance.

The CPGs are organized by subject-matter in the following chapters:

  • General
  • Biologics
  • Devices
  • Human Drugs
  • Food, Colors, and Cosmetics
  • Veterinary Medicine

FDA staff who identify a need for a new or revised CPG should contact the relevant FDA Center. For Chapter 1 (General) inquiries, contact the Division of Inspectorate Policy (DIP) within the Office of Inspectional Performance Optimization, Office of Inspections and Investigations at oiioipodipio@fda.hhs.gov. DIP can also help identify the appropriate contact if needed.



 

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