Postmarketing safety reporting.

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Biologics
  6. Licensing
  7. Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses
  8. Postmarketing safety reporting.

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§ 601.44 Postmarketing safety reporting.

Biological products approved under this program are subject to the postmarketing recordkeeping and safety reporting applicable to all approved biological products.


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