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GDUFA II Reviews Start Strong With High First-Cycle Approval Rate

 
• By Derrick Gingery

Performance numbers are likely to fluctuate over the course of the program, but the rate of first-cycle approvals during the first month of the new user fee program is more than double the rate during the last year of the old iteration. 

FDA entrance sign 2016

GDUFA II began with a much higher first-cycle ANDA approval rate than has been seen in previously, a promising sign as the US FDA works to increase generic approvals in the hopes of lowering drug prices.

The agency's Office of Generic Drugs reported 26 full first-cycle approvals out of 87 issued in October, the first month...

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