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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 - PART 601—LICENSING
Subpart A [§ 601.2 - § 601.9] - Subpart A—General Provisions
Subpart B - Subpart B [Reserved]
Subpart C [§ 601.12 - § 601.29] - Subpart C—Biologics Licensing
Subpart D [§ 601.30 - § 601.35] - Subpart D—Diagnostic Radiopharmaceuticals
Subpart E [§ 601.40 - § 601.46] - Subpart E—Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses
Subpart F [§ 601.50 - § 601.51] - Subpart F—Confidentiality of Information
Subpart G [§ 601.70 - § 601.70] - Subpart G—Postmarketing Studies
Subpart H [§ 601.90 - § 601.95] - Subpart H—Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible
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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