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Federal Regulations

Title 45 Code of Federal Regulations Part 46 (45 CFR 46) -- Protection of Human Subjects (Revised October 1, 2003)

Title 21 Food and Drugs (Regulations applied by the Food and Drug Administration relevant to human subjects research)

          Part 11 Electronic Records
         
          Part 50 Protection of Human Subjects
         
          Part 56 Institutional Review Boards
         
          Part 312 Investigational New Drug Application
         
          Part 314 Application for FDA Approval to Market a New Drug, Biologic or an
          Antibiotic Drug for Human Use

          Part 600 Biologic Products

          Part 807 Application for Premarket Notification (510k)
                            
          Part 812 Investigational Device Exemptions
         
          Part 814 Premarket Approval of a Medical Device

          Other FDA Forms
            

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