Title 21

PART 314 SUBPART H

Subpart H - Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses Source:57 FR 58958, Dec. 11, 1992, unless otherwise noted.

• 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.

21:5.0.1.1.4.8.1.1	SECTION 314.500	314.500 Scope.
21:5.0.1.1.4.8.1.2	SECTION 314.510	314.510 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
21:5.0.1.1.4.8.1.3	SECTION 314.520	314.520 Approval with restrictions to assure safe use.
21:5.0.1.1.4.8.1.4	SECTION 314.530	314.530 Withdrawal procedures.
21:5.0.1.1.4.8.1.5	SECTION 314.540	314.540 Postmarketing safety reporting.
21:5.0.1.1.4.8.1.6	SECTION 314.550	314.550 Promotional materials.
21:5.0.1.1.4.8.1.7	SECTION 314.560	314.560 Termination of requirements.

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