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News: FDA receives notice from GAO to improve the First Cycle Generic Approval Rate

The Government Accountable Office (GAO) has demanded the FDA to improve the rate of first cycle approvals for generic drugs considering an increase in the clarity and consistency of reviewer comments.

As of FY2015-2017 reports, only 12 percent of the generics were approved in the first review cycle while on an average the generic applicant undergoes through three review cycles, even though the FDA has worked to bring out a substantial increase in the first cycle approvals in recent years. However, this rate is considerably high when compared to the 2012 first cycle review rate of only 1 percent, before the enactment of Drug User Fee Amendments (GDUFA).