[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: 21CFR314.100]

[Page 134]
 
                        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.  314.100  Timeframes for reviewing applications and abbreviated 

    Source: 50 FR 7493, Feb. 22, 1985, unless otherwise noted. 
Redesignated at 57 FR 17983, Apr. 28, 1992.


applications.

    (a) Within 180 days of receipt of an application for a new drug 
under section 505(b) of the act, or of an abbreviated application for a 
new drug under section 505(j) of the act, FDA will review it and send 
the applicant either an approval letter under Sec.  314.105, or an 
approvable letter under Sec.  314.110, or a not approvable letter under 
Sec.  314.120. This 180-day period is called the ``review clock.''
    (b) During the review period, an applicant may withdraw an 
application under Sec.  314.65 or an abbreviated application under Sec.  
314.99 and later resubmit it. FDA will treat the resubmission as a new 
application or abbreviated application.
    (c) The review clock may be extended by mutual agreement between FDA 
and an applicant or as provided in Sec. Sec.  314.60 and 314.96, as the 
result of a major amendment.

[57 FR 17987, Apr. 28, 1992, as amended at 64 FR 402, Jan. 5, 1999]