Section 314.100 - Timeframes for reviewing applications and abbreviated applications
1 Analyses of this regulation by attorneys
HHS OIG Announces FY 2008 Work Plan; 9 New FDA Studies Identified, Including Clinical Trial Oversight and Off-Label Promotion
Hyman, Phelps & McNamara, P.C.October 30, 2007Continued StudiesGeneric Drug Approval Process - OIG will review FDA’s timeframes for reviewing original generic drug applications and identify factors that affect the timely review of these applications. FDA is required by 21 CFR § 314.100 to approve or disapprove applications for generic drugs within 180 days of submission. As of 2006, the agency had a backlog of approximately 1,000 generic drug applications, one-third of which had exceeded the 180-day statutory time limit.