GroundRules
21 CFR 601.44: 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 E—Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses
Biological products approved under this program are subject to the postmarketing recordkeeping and safety reporting applicable to all approved biological products.
Collected 2026-08-27T02:24:47Z. Source file · JSON