Statutes, codes, and regulations
Code of Federal Regulations
Title 21 - FOOD AND DRUGSChapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubchapter D - DRUGS FOR HUMAN USEPart 314 - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Subpart D - FDA ACTION ON APPLICATIONS AND ABBREVIATED APPLICATIONS
Section 314.160 - Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn

21 C.F.R. § 314.160

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Current through March 31, 2024
Section 314.160 - Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn

Upon the Food and Drug Administration's own initiative or upon request of an applicant, FDA may, on the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval. FDA will publish a notice in the FEDERAL REGISTER announcing the approval.

21 C.F.R. §314.160

57 FR 17995, Apr. 28, 1992