Title 21

PART 601 SUBPART H

Subpart H - Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible Source:67 FR 37996, May 31, 2002, unless otherwise noted.

• 15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353, 355, 356b, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C. 216, 241, 262, 263, 264; sec 122, Pub. L. 105-115, 111 Stat. 2322 (21 U.S.C. 355 note).
• Source: 38 FR 32052, Nov. 20, 1973, unless otherwise noted.

21:7.0.1.1.2.8.1.1	SECTION 601.90	601.90 Scope.
21:7.0.1.1.2.8.1.2	SECTION 601.91	601.91 Approval based on evidence of effectiveness from studies in animals.
21:7.0.1.1.2.8.1.3	SECTION 601.92	601.92 Withdrawal procedures.
21:7.0.1.1.2.8.1.4	SECTION 601.93	601.93 Postmarketing safety reporting.
21:7.0.1.1.2.8.1.5	SECTION 601.94	601.94 Promotional materials.
21:7.0.1.1.2.8.1.6	SECTION 601.95	601.95 Termination of requirements.

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