Postmarketing safety reporting.

  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. Applications for FDA Approval to Market a New Drug
  7. Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses
  8. Postmarketing safety reporting.

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§ 314.540 Postmarketing safety reporting.

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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