21 C.F.R. § 601.93 Postmarketing safety reporting.
Title 21 - Food and Drugs
Biological products approved under this subpart are subject to the postmarketing recordkeeping and safety reporting applicable to all approved biological products.
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.
