C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER F—BIOLOGICS › PART 601—LICENSING › Subpart E—Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses

21 C.F.R. § 601.44

Postmarketing safety reporting

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