[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR314.65]

[Page 112]
 
                        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 B_Applications
 
Sec.  314.65  Withdrawal by the applicant of an unapproved application.

    An applicant may at any time withdraw an application that is not yet 
approved by notifying the Food and Drug Administration in writing. The 
agency will consider an applicant's failure to respond within 10 days to 
an approvable letter under Sec.  314.110 or a not approvable letter 
under Sec.  314.120 to be a request by the applicant to withdraw the 
application. A decision to withdraw the application is without prejudice 
to refiling. The agency will retain the application and will provide a 
copy to the applicant on request under the fee schedule in Sec.  20.45 
of FDA's public information regulations.

[50 FR 7493, Feb. 22, 1985, as amended at 68 FR 25287, May 12, 2003]