21 C.F.R. § 314.630 Postmarketing safety reporting.
Title 21 - Food and Drugs
Drug products approved under this subpart are subject to the postmarketing recordkeeping and safety reporting requirements applicable to all approved drug products, as provided in §§314.80 and 314.81.
Title 21: Food and Drugs
PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Subpart I—Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible
§ 314.630 Postmarketing safety reporting.
