GroundRules
21 CFR 601.93: Postmarketing safety reporting.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER F—BIOLOGICS
- PART 601—LICENSING
- Subpart H—Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible
Biological products approved under this subpart are subject to the postmarketing recordkeeping and safety reporting applicable to all approved biological products.
Collected 2026-08-27T02:24:47Z. Source file · JSON