§314.630. Postmarketing safety reporting.
21 C.F.R. § 314.630
Drug products approved under this subpart are subject to the postmarketing recordkeeping and safety reporting requirements applicable to all approved drug products, as provided in §§ 314.80 and 314.81.
Notes, amendments, and revision history
Source
Source: 67 FR 37995, May 31, 2002, unless otherwise noted.
Authority
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 355f, 356, 356a, 356b, 356c, 356e, 360cc, 360ddd, 360ddd-1, 371, 374, 379e, 379k-1.
Source
Source: 50 FR 7493, Feb. 22, 1985, unless otherwise noted.