Title 21

PART 310 SUBPART A

Subpart A - General Provisions

• 21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f, 360j, 360hh-360ss, 361(a), 371, 374, 375, 379e, 379k-l; 42 U.S.C. 216, 241, 242(a), 262.

21:5.0.1.1.2.1.1.1	SECTION 310.3	310.3 Definitions and interpretations.
21:5.0.1.1.2.1.1.2	SECTION 310.4	310.4 Biologics; products subject to license control.
21:5.0.1.1.2.1.1.3	SECTION 310.6	310.6 Applicability of “new drug” or safety or effectiveness findings in drug efficacy study implementation notices and notices of opportunity for hearing to identical, related, and similar drug products.

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