21 C.F.R. § 314.160 Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.
Title 21 - Food and Drugs
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the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval.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 [57 FR 17995, Apr. 28, 1992]
Title 21: Food and Drugs
PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
Subpart D—FDA Action on Applications and Abbreviated Applications
§ 314.160 Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.
