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CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER F—BIOLOGICS (parts 600 to 680) > PART 601—LICENSING > SUBPART E—Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses (§601.40 to §601.46) > 601.44—Postmarketing safety reporting.
601.44—Postmarketing safety reporting.
Biological products approved under this program are subject to the postmarketing recordkeeping and safety reporting applicable to all approved biological products.