§601.32. General factors relevant to safety and effectiveness.
21 C.F.R. § 601.32
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
Source
Source: 64 FR 26668, May 17, 1999, unless otherwise noted.
Authority
Authority: 15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353, 355, 356b, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C. 216, 241, 262, 263, 264; sec 122, Pub. L. 105-115, 111 Stat. 2322 (21 U.S.C. 355 note), sec 7002(e), Pub. L. 111-148, 124 Stat. 817, as amended by sec. 607, Division N, Pub. L. 116-94, 133 Stat. 3127.
Source
Source: 38 FR 32052, Nov. 20, 1973, unless otherwise noted.