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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 B - Subpart B—Investigational New Drug Application (IND)
§ 312.20 - Requirement for an IND.
§ 312.21 - Phases of an investigation.
§ 312.22 - General principles of the IND submission.
§ 312.23 - IND content and format.
§ 312.30 - Protocol amendments.
§ 312.31 - Information amendments.
§ 312.32 - IND safety reporting.
§ 312.33 - Annual reports.
§ 312.38 - Withdrawal of an IND.
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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