Food & Drug Administration (FDA)

• Link to FDA Website
  
  
• FDA Guidance
• Acceptance of Foreign Clinical Studies Not Conducted Under an IND - FAQ
• Guidance for IRBs, Clinical Investigators, and Sponsors - FDA Inspections of Clinical Investigators
• FDA Medwatch Information
• FDA Information Sheets-Guidance for IRBs and Clinical Investigators
• FDA Resources
• Guideline for Industry - E6 Good Clinical Practice
• Protection of Human Subjects (21 CFR Part 50)
• Institutional Review Boards (21 CFR Part 56)
• Investigational New Drug Application (21 CFR Part 312)
• Drug Application Form 1571and 1572
• Applications for FDA Approval to Market a New Drug (21 CRF Part 314)
• Biological Products (21 CFR Part 600)
• FDA Centers (21 CRF Part 814)
• Center for Biologics Evaluation and Research (CBER)
• Center for Drug Evaluation and Research (CDER)
• Certificate of Confidentiality (COC) -  FDA's Certificates of Confidentiality Application Instructions.
• Clinical Investigator resources
  
  
• FDA forms (e.g. 1571, 1572, etc.)
  
  
• FDA Studies - If a Certificate of Confidentiality is needed for a study involving investigational new drugs (IND), follow the FDA's Certificates of Confidentiality Application Instructions. If a study is also NIH funded, applications for both agencies may be required. Coordinate with the FDA first.