Useful Links

• FDA Center for Drug Evaluation and Research
  • Freedom of Information Act
  • Warning letters
  • Information Sheets for IRBs and Clinical Investigators
  • IDE Policies and Procedure
  • Bioresearch Monitoring Information Systems File (Clinical Investigators, CROs and IRBs form FDA 1571 & 1572s)
  • ICH (International Conference on Harmonisation)
  
  
• FDA Good Clinical Practice Regulations
  • Title 21, Part 50 (Informed Consent)
  • Title 21, Part 56 (Institutional Review Boards)
  • Title 21, Part 312 (Investigational New Drug Application)
  • Title 21, Part 812 (Investigational Device Exemption)
  
  
• CDRH Guidance
  
  
• CDRH Device Advice
  
  
• Human Research Protections
  • OHRP IRB Guidebook
  • OHRP IRB and Assurances Database
  
  
• National Institutes of Health
  
  
• The National Bioethics Advisory Commission
  
  
• PhRMA - Info about the Pharmaceutical industry