1. Generics Bulletin

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.

The Senate Health, Education, Labor and Pensions Committee overwhelmingly approved the amended FDA Reauthorization Act 21-2 on May 11, sending it to the Senate floor for final consideration. The legislation...

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