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Regulations last checked for updates: May 14, 2025
Title 21 - Food and Drugs last revised: May 12, 2025
All Titles
Title 21
Chapter I
Part 601
Subpart E - Subpart E—Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses
§ 601.40 - Scope.
§ 601.41 - Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
§ 601.42 - Approval with restrictions to assure safe use.
§ 601.43 - Withdrawal procedures.
§ 601.44 - Postmarketing safety reporting.
§ 601.45 - Promotional materials.
§ 601.46 - Termination of requirements.
authority:
15 U.S.C. 1451-1561
;
21 U.S.C. 321
,
351
,
352
,
353
,
355
,
356b
,
360
,
360
c-360f,
360
h-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.
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