1. Regulations
  2. title 21
  3. chapter I-i4
  4. part 314
  5. subpart H
  6. § 314.540

View all text of Subpart H [§ 314.500 - § 314.560]

§ 314.540 - Postmarketing safety reporting.

Drug products approved under this program are subject to the postmarketing recordkeeping and safety reporting applicable to all approved drug products, as provided in §§ 314.80 and 314.81.

AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 355f, 356, 356a, 356b, 356c, 356e, 360cc, 371, 374, 379e, 379k-1.

SOURCE: 50 FR 7493, Feb. 22, 1985, unless otherwise noted.

CITE AS: 21 CFR 314.540