§ 601.32. General factors relevant to safety and effectiveness.
60 words·~1 min read·
/us/cfr/t21/s§ 601.32·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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.