GroundRules
21 CFR 314.540: 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 D—DRUGS FOR HUMAN USE
- PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
- Subpart H—Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses
Drug products approved under this program are subject to the postmarketing recordkeeping and safety reporting applicable to all approved drug products, as provided in §§ 314.80 and 314.81.
Collected 2026-08-27T02:24:47Z. Source file · JSON