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Regulations last checked for updates: Nov 22, 2024
Title 21 - Food and Drugs last revised: Nov 19, 2024
All Titles
Title 21
Chapter I
Part 314
Subpart H - Subpart H—Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses
§ 314.500 - Scope.
§ 314.510 - Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
§ 314.520 - Approval with restrictions to assure safe use.
§ 314.530 - Withdrawal procedures.
§ 314.540 - Postmarketing safety reporting.
§ 314.550 - Promotional materials.
§ 314.560 - Termination of requirements.
authority:
21 U.S.C. 321
,
331
,
351
,
352
,
353
,
355
,
355
a,
355
f,
356
,
356
a,
356
b,
356
c,
356
e,
360cc
,
371
,
374
,
379e
,
379k
source:
50 FR 7493, Feb. 22, 1985, unless otherwise noted.
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