§315.3. General factors relevant to safety and effectiveness.
21 C.F.R. § 315.3
FDA's determination of the safety and effectiveness of a diagnostic radiopharmaceutical includes consideration of the following:
The proposed use of the diagnostic radiopharmaceutical in the practice of medicine,
The pharmacological and toxicological activity of the diagnostic radiopharmaceutical (including any carrier or ligand component of the diagnostic radiopharmaceutical), and
The estimated absorbed radiation dose of the diagnostic radiopharmaceutical.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 371, 374, 379e; sec. 122, Pub. L. 105-115, 111 Stat. 2322 (21 U.S.C. 355 note).
Source
Source: 64 FR 26667, May 17, 1999, unless otherwise noted.