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ANDA Review Consistency Could Emerge As A GDUFA Problem

 
• By Derrick Gingery

Industry officials are concerned all the new FDA hires to handle generic drug user fee program issues will lead to varied interpretations of agency policy and potentially create first-to-file or other problems.

As FDA remakes the ANDA review system into one that is more speedy and formal, it likely will have to battle consistency problems, particularly as new employees adapt to the soon-to-be-ticking review clock.

The agency plans to train new hires on the new policies, but industry is concerned the inexperienced staff may clash...

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More from North America

FY 2025 Generic Drugs By The Numbers

 
• By Derrick Gingery

New FDA data shows a potentially concerning drop in ANDA submissions, while the first-cycle approval rate increased.

Biohaven’s Troriluzole And The Era Of Real-Time Complete Response Letters

 
• By Michael McCaughan

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• By Sarah Karlin-Smith

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