Title 21: Food and Drugs
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/ PART 601 - LICENSING
/ Subpart H - Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible / § 601.93 Postmarketing safety reporting.
§ 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.