General Provisions

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Drugs for Human Use
  6. New Drugs
  7. General Provisions

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Section
310.3

Definitions and interpretations.

Section
310.4

Biologics; products subject to license control.

Section
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.