CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE (parts 300 to 370) > PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG > SUBPART D—FDA Action on Applications and Abbreviated Applications (§314.100 to §314.170) > 314.160—Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.

314.160—Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.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the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval.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.

Code of Federal Regulations

[57 FR 17995, Apr. 28, 1992]