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Last Updated: 10/28/16

Additional Sources of Information

Developing Medical Imaging Drug and Biological Products

  • Part 1: Conducting Safety Assessments [PDF] (Issued 6/17/2004, Posted 6/17/2004)
  • Part 2: Clinical Indications [PDF] (Issued 6/17/2004, Posted 6/17/2004)

Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs (PDF)

21 CFR Part 315 Diagnostic Radiopharmaceuticals (may load slowly)

FDA Regulatory Information

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use