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 H - Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses
  7. 21 CFR § 314.540
21 CFR § 314.540
Postmarketing safety reporting
June 25, 2020
CFR

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

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§ 314.530 Withdrawal procedures
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§ 314.560 Termination of requirements

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