21 CFR 315.3 - General factors relevant to safety and effectiveness.
FDA's determination of the safety and effectiveness of a diagnostic radiopharmaceutical includes consideration of the following:
(b) The pharmacological and toxicological activity of the diagnostic radiopharmaceutical (including any carrier or ligand component of the diagnostic radiopharmaceutical), and
Title 21 published on 2013-04-01
no entries appear in the Federal Register after this date.