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GDUFA II: Priority Reviews Considered For Some ANDAs

 
• By Derrick Gingery

New pathway could restart argument between industry and FDA over what qualifies for expedited review.

FDA’s generic drug review system may gain a priority review pathway, more closely aligning it with the review system for new drugs.

Minutes of the Oct. 21 generic drug user fee program (GDUFA) reauthorization meeting state that FDA “discussed having...

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