1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter D - DRUGS FOR HUMAN USE
  5. Part 314 - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
  6. Subpart I - Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible
  7. 21 CFR § 314.630
21 CFR § 314.630
Postmarketing safety reporting
June 25, 2020
CFR

Drug products approved under this subpart are subject to the postmarketing recordkeeping and safety reporting requirements applicable to all approved drug products, as provided in §§314.80 and 314.81.

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§ 314.620 Withdrawal procedures
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§ 314.640 Promotional materials

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