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Generic Priority Review Expanded In Senate User Fee Bill

 
• By Derrick Gingery

Amendment added during markup would require eight-month review of ANDAs for shortage drugs and those with limited competition, as well as pre-submission meetings.

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Legislation expanding the US FDA's generic drug priority review pathway beyond sole-source drugs to generics entering markets with "limited competition" was added to the Senate's user fee reauthorization bill.

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