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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 H—Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible (§601.90 to §601.95) > 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.