Positron Emission Tomography (PET)

The Food and Drug Administration (FDA) today is announcing a proposed current good manufacturing practices (CGMP) regulation for the production of Positron Emission Tomography (PET) drugs. The regulation, which establishes minimum standards for the production and testing of PET drug products, is intended to ensure that PET drug products meet the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as to safety, identity, strength, quality, and purity.

• Proposed Rule: Current Good Manufacturing Practice for PET Drugs (PDF - 165KB)  (issued 9/1/2005)
• Draft Guidance: PET Drug Products – Current Good Manufacturing Practice (CGMP)
  • Federal Register Notice (PDF - 26KB)
  • The Draft Guidance (PDF - 277KB)
• Sample Template for Component Record Keeping (PDF - 24KB)
• Questions and Answers
• Historical Information on PET