Title 21

PART 314 SUBPART I

Subpart I - Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible Source:67 FR 37995, May 31, 2002, unless otherwise noted.

• 21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 355f, 356, 356a, 356b, 356c, 356e, 360cc, 371, 374, 379e, 379k-1.
• Source: 50 FR 7493, Feb. 22, 1985, unless otherwise noted.

21:5.0.1.1.4.9.1.1	SECTION 314.600	314.600 Scope.
21:5.0.1.1.4.9.1.2	SECTION 314.610	314.610 Approval based on evidence of effectiveness from studies in animals.
21:5.0.1.1.4.9.1.3	SECTION 314.620	314.620 Withdrawal procedures.
21:5.0.1.1.4.9.1.4	SECTION 314.630	314.630 Postmarketing safety reporting.
21:5.0.1.1.4.9.1.5	SECTION 314.640	314.640 Promotional materials.
21:5.0.1.1.4.9.1.6	SECTION 314.650	314.650 Termination of requirements.

---