StacksVerified U.S. regulatory reference

21 CFR §601.32

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
FDA's determination of the safety and effectiveness of a diagnostic radiopharmaceutical includes consideration of the following:
  1. (a)The proposed use of the diagnostic radiopharmaceutical in the practice of medicine;
  2. (b)The pharmacological and toxicological activity of the diagnostic radiopharmaceutical (including any carrier or ligand component of the diagnostic radiopharmaceutical); and
  3. (c)The estimated absorbed radiation dose of the diagnostic radiopharmaceutical.