21 C.F.R. § 314.650 Termination of requirements.
Title 21 - Food and Drugs
If FDA determines after approval under this subpart that the requirements established in §§314.610(b)(2), 314.620, and 314.630 are no longer necessary for the safe and effective use of a drug product, FDA will so notify the applicant. Ordinarily, for drug products approved under §314.610, these requirements will no longer apply when FDA determines that the postmarketing study verifies and describes the drug product's clinical benefit. For drug products approved under §314.610, the restrictions would no longer apply when FDA determines that safe use of the drug product can be ensured through appropriate labeling. FDA also retains the discretion to remove specific postapproval requirements upon review of a petition submitted by the sponsor in accordance with §10.30 of this chapter.
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
§ 314.650 Termination of requirements.
