1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter F - BIOLOGICS
  5. Part 601 - LICENSING
  6. Subpart E - Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses
  7. 21 CFR § 601.44
21 CFR § 601.44
Postmarketing safety reporting
June 25, 2020
CFR

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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§ 601.43 Withdrawal procedures
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§ 601.45 Promotional materials

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