Title 21

PART 601 SUBPART C

Subpart C - Biologics Licensing

• 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).
• 38 FR 32052, Nov. 20, 1973, unless otherwise noted.

21:7.0.1.1.2.3.1.1	SECTION 601.12	601.12 Changes to an approved application.
21:7.0.1.1.2.3.1.2	SECTION 601.14	601.14 Regulatory submissions in electronic format.
21:7.0.1.1.2.3.1.3	SECTION 601.15	601.15 Foreign establishments and products: samples for each importation.
21:7.0.1.1.2.3.1.4	SECTION 601.20	601.20 Biologics licenses; issuance and conditions.
21:7.0.1.1.2.3.1.5	SECTION 601.21	601.21 Products under development.
21:7.0.1.1.2.3.1.6	SECTION 601.22	601.22 Products in short supply; initial manufacturing at other than licensed location.
21:7.0.1.1.2.3.1.7	SECTION 601.27	601.27 Pediatric studies.
21:7.0.1.1.2.3.1.8	SECTION 601.28	601.28 Annual reports of postmarketing pediatric studies.
21:7.0.1.1.2.3.1.9	SECTION 601.29	601.29 Guidance documents.

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