Title 21

PART 312 SUBPART C

Subpart C - Administrative Actions

• 21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262.
• 52 FR 8831, Mar. 19, 1987, unless otherwise noted.

21:5.0.1.1.3.3.1.1	SECTION 312.40	312.40 General requirements for use of an investigational new drug in a clinical investigation.
21:5.0.1.1.3.3.1.2	SECTION 312.41	312.41 Comment and advice on an IND.
21:5.0.1.1.3.3.1.3	SECTION 312.42	312.42 Clinical holds and requests for modification.
21:5.0.1.1.3.3.1.4	SECTION 312.44	312.44 Termination.
21:5.0.1.1.3.3.1.5	SECTION 312.45	312.45 Inactive status.
21:5.0.1.1.3.3.1.6	SECTION 312.47	312.47 Meetings.
21:5.0.1.1.3.3.1.7	SECTION 312.48	312.48 Dispute resolution.

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