Code of Federal Regulations · Section

§ 601.32 — General Factors Relevant To Safety And Effectiveness

21 C.F.R. § 601.32

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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.

21 C.F.R. § 601.31 21 C.F.R. § 601.33

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