GMP Publications - Code of Federal Regulation Handbooks by the FDA

21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R1) - Good Clinical Practice Handbook - Includes the June 24th, 2011 Changes

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US FDA Title 21 CFR Parts

  • Part 11 Electronic Records
  • Part 50 Protection of human subjects
  • Part 54 Financial disclosure by clinical investigators
  • Part 56 Institutional Review Boards
  • Part 312 Investigational New Drug Application
  • Part 314 Application to the FDA to Market a New Drug

    International Conference on Harmonisation Regulations

  • ICH E2A Good Clinical Practice
  • ICH E6 (R1) Clinical Safety Data Management












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