21 CFR 315.3 - General factors relevant to safety and effectiveness.

§ 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:
(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.

Title 21 published on 2013-04-01

no entries appear in the Federal Register after this date.

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