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ANDA Approval Times Get Optimistic Estimate In Budget Request

 
• By Derrick Gingery

US FDA has historically overestimated generic review performance in budget requests, but recently underestimated the number of ANDAs it expects to approve.

Samples of medicines, tablets, capsules, vitamins, and placebo

The US FDA continues to give overly optimistic predictions of median ANDA times to approval, a popular performance measure for the generic drugs program.

FDA estimates that the median approval time will be 38.25 months in fiscal year 2017, a decrease of more than a month from the FY 2016 actual time, according to...

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