Title 21

PART 601 SUBPART E

Subpart E - Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses Source:57 FR 58959, Dec. 11, 1992, unless otherwise noted.

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

21:7.0.1.1.2.5.1.1	SECTION 601.40	601.40 Scope.
21:7.0.1.1.2.5.1.2	SECTION 601.41	601.41 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
21:7.0.1.1.2.5.1.3	SECTION 601.42	601.42 Approval with restrictions to assure safe use.
21:7.0.1.1.2.5.1.4	SECTION 601.43	601.43 Withdrawal procedures.
21:7.0.1.1.2.5.1.5	SECTION 601.44	601.44 Postmarketing safety reporting.
21:7.0.1.1.2.5.1.6	SECTION 601.45	601.45 Promotional materials.
21:7.0.1.1.2.5.1.7	SECTION 601.46	601.46 Termination of requirements.

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