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Cancer Imaging Program

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Programs & Resources

Additional Sources of Information

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

U.S. Department of Health and Human Services  |  National Institutes of Health  |  National Cancer Institute  |  USA.gov

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