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FDA Approving Complex Generics Pre-ANDA Meeting Requests At Higher Rates

Uptrend Could Signal Surge In Complex-Generic Approvals

 
• By Joanne S. Eglovitch

Approval rates for complex-drug pre-ANDA meeting requests are climbing. FDA’s hope is that the meetings will hasten approvals of these hard-to-manufacture generics, which could put a dent in US healthcare costs.

FDA entrance sign 2016

Generic drug firms appear to be gaining a better understanding of what it takes to win US FDA approval of requests for meetings the agency recently established to help firms strengthen their applications for approval of complex generic drugs.

But while FDA has been approving a greater percentage of the meeting requests in recent months, it remains to be seen whether those meetings will turn hasten agency approval of...

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