Subpart I—Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible

1. CFR
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3. Title 21
4. ›
5. Chapter I
6. ›
7. Part 314
8. ›
9. Subpart I

Sections

Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.

• 314.600
  § 314.600 Scope.
• 314.610
  § 314.610 Approval based on evidence of effectiveness from studies in animals.
• 314.620
  § 314.620 Withdrawal procedures.
• 314.630
  § 314.630 Postmarketing safety reporting.
• 314.640
  § 314.640 Promotional materials.
• 314.650
  § 314.650 Termination of requirements.