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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Compliance Program 7348.809 - Part VI - References, Attachments, and Program Contacts

  1. REFERENCES
    1. FDA Laws

      Federal Food, Drug, and Cosmetic Act (FD&C Act)

       
    1. Most Relevant 21 CFR Regulations

      Part 50Protection of Human Subjects
      Part 56Institutional Review Boards
      Part 312 Investigational New Drug Application
      Part 812 Investigational Device Exemptions
       
    1. Other 21 CFR Regulations

      Part 11  Electronic Records; Electronic Signatures,
      Part 814 Premarket Approval of Medical Devices (includes HDE Requirements in 814.100)
      Part 320Bioavailability and Bioequivalence Requirements

       
    1. FDA Guidelines, Guidances, and Inspection Guides

       
  1. PROGRAM CONTACTS 

     
    1. When medical, technical or scientific questions or issues arise from a specific assignment or if additional information is required about a specific assignment, consult the Center contact identified in the assignment. 

       
    2. For operational questions, contact: Office of the Associate Commissioner for Regulatory Affairs

      Office of Regional Operations (ORO)
      Division of Domestic Field Investigations:
      301-796-5403, FAX 301-827-4090

       
    3. For questions about GCP and Compliance program issues, specific to a Center product area, contact:

      Center for Drug Evaluation and Research (CDER)
      Office of Scientific Investigations:
      301-796-3399, FAX 301-847-8748

      Center for Biologics Evaluation and Research (CBER)
      Bioresearch Monitoring Staff:
      301-827-6221, FAX 301-827-6748

      Center for Devices and Radiological Health (CDRH)
      Division of Bioresearch Monitoring:
      301-796-5490, FAX 301-847-8136

      Center for Food Safety and Applied Nutrition (CFSAN)
      Office of Food Additive Safety;
      Division of Petition Review
      240-402-1265, FAX 301-436-2972

       
    4. For crosscutting questions about GCP policy and program issues impacting the Agency’s BIMO Programs, or suggestions to improve this compliance program, contact:

      Office of Good Clinical Practice
      Office of Special Medical Programs
      Office of the Commissioner
      301-796-8340, FAX 301-847-8640