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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 with veterans over interpretations of the new GDUFA-inspired review criteria.

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More from North America

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
• By Derrick Gingery

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

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• By Bridget Silverman

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