General factors relevant to safety and effectiveness.

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.