[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR314.160]

[Page 159]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG--Table of Contents
 
   Subpart D--FDA Action on Applications and Abbreviated Applications
 
Sec. 314.160  Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.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suspended, or withdrawn approval.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.

[57 FR 17995, Apr. 28, 1992]