21 C.F.R. § 314.540 Postmarketing safety reporting.
Title 21 - Food and Drugs
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.
Title 21: Food and Drugs
PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Subpart H—Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses
§ 314.540 Postmarketing safety reporting.
