1. Regulations
  2. title 21
  3. chapter I-i6
  4. part 601
  5. subpart E
  6. § 601.44

View all text of Subpart E [§ 601.40 - § 601.46]

§ 601.44 - Postmarketing safety reporting.

Biological products approved under this program are subject to the postmarketing recordkeeping and safety reporting applicable to all approved biological products.

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: 38 FR 32052, Nov. 20, 1973, unless otherwise noted.

CITE AS: 21 CFR 601.44