§ 601.32 General factors relevant to safety and effectiveness.
Current through Sep 8, 2026 · Read all of Part 601
FDA's determination of the safety and effectiveness of a diagnostic radiopharmaceutical includes consideration of the following:
(a) The proposed use of the diagnostic radiopharmaceutical in the practice of medicine;
(b) The pharmacological and toxicological activity of the diagnostic radiopharmaceutical (including any carrier or ligand component of the diagnostic radiopharmaceutical); and
(c) The estimated absorbed radiation dose of the diagnostic radiopharmaceutical.