Title 21

PART 312 SUBPART A

Subpart A - General Provisions

• 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.

21:5.0.1.1.3.1.1.1	SECTION 312.1	312.1 Scope.
21:5.0.1.1.3.1.1.2	SECTION 312.2	312.2 Applicability.
21:5.0.1.1.3.1.1.3	SECTION 312.3	312.3 Definitions and interpretations.
21:5.0.1.1.3.1.1.4	SECTION 312.6	312.6 Labeling of an investigational new drug.
21:5.0.1.1.3.1.1.5	SECTION 312.7	312.7 Promotion of investigational drugs.
21:5.0.1.1.3.1.1.6	SECTION 312.8	312.8 Charging for investigational drugs under an IND.
21:5.0.1.1.3.1.1.7	SECTION 312.10	312.10 Waivers.

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