Title 21

PART 312 SUBPART B

Subpart B - Investigational New Drug Application (IND)

• 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.

21:5.0.1.1.3.2.1.1	SECTION 312.20	312.20 Requirement for an IND.
21:5.0.1.1.3.2.1.2	SECTION 312.21	312.21 Phases of an investigation.
21:5.0.1.1.3.2.1.3	SECTION 312.22	312.22 General principles of the IND submission.
21:5.0.1.1.3.2.1.4	SECTION 312.23	312.23 IND content and format.
21:5.0.1.1.3.2.1.5	SECTION 312.30	312.30 Protocol amendments.
21:5.0.1.1.3.2.1.6	SECTION 312.31	312.31 Information amendments.
21:5.0.1.1.3.2.1.7	SECTION 312.32	312.32 IND safety reporting.
21:5.0.1.1.3.2.1.8	SECTION 312.33	312.33 Annual reports.
21:5.0.1.1.3.2.1.9	SECTION 312.38	312.38 Withdrawal of an IND.

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