21 C.F.R. § 601.44 Postmarketing safety reporting.
Title 21 - Food and Drugs
Biological products approved under this program are subject to the postmarketing recordkeeping and safety reporting applicable to all approved biological products.
Title 21: Food and Drugs
PART 601—LICENSING
Subpart E—Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses
§ 601.44 Postmarketing safety reporting.
