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e-CFR data is current as of September 17, 2020

Title 21Chapter ISubchapter FPart 601Subpart H → §601.93


Title 21: Food and Drugs
PART 601—LICENSING
Subpart H—Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible


§601.93   Postmarketing safety reporting.

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

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