ANDA Time To Approval, First Action Curves Need To Bend

FDA generics office says improvement will be noticeable soon, but output can’t dramatically increase overnight.

An FDA study determined reviewers still have a ways to go to begin acting on ANDAs within 10 months – the deadline they will be required to meet in two years under the generic user fee program.

The results of the internal review can’t be overly pleasing for sponsors; most applications still require several years to gain...

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