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21 C.F.R. § 601.32   General factors relevant to safety and effectiveness.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 601—LICENSING
Subpart D—Diagnostic Radiopharmaceuticals

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§ 601.32   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.

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