21 C.F.R. § 314.100 Timeframes for reviewing applications and abbreviated applications.
Title 21 - Food and Drugs
(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 §314.105, or an approvable letter under §314.110, or a not approvable letter under §314.120. This 180-day period is called the “review clock.” (b) During the review period, an applicant may withdraw an application under §314.65 or an abbreviated application under §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 §§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]
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
§ 314.100 Timeframes for reviewing applications and abbreviated applications.
