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Regulations last checked for updates: Jun 14, 2025
Title 21 - Food and Drugs last revised: Jun 03, 2025
All Titles
Title 21
Chapter I
Part 312
Subpart I - Subpart I—Expanded Access to Investigational Drugs for Treatment Use
§ 312.300 - General.
§ 312.305 - Requirements for all expanded access uses.
§ 312.310 - Individual patients, including for emergency use.
§ 312.315 - Intermediate-size patient populations.
§ 312.320 - Treatment IND or treatment protocol.
authority:
21 U.S.C. 321
,
331
,
351
,
352
,
353
,
355
,
360bbb
,
371
;
42 U.S.C. 262.
source:
52 FR 8831, Mar. 19, 1987, unless otherwise noted.
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