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.