1. Pink Sheet

ANDAs Can Get Priority, Eight-Month Reviews Under User Fee Deal

 
• By Derrick Gingery

GDUFA II gives certain generics the possibility of an even faster review clock, which burnishes FDA's credentials in the drug pricing debate, but in order to take advantage, applications will need to be of high quality in addition to addressing a public health priority.

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FDA will offer formal priority reviews for some ANDAs beginning in fiscal year 2018 as part of the reauthorized generic drug user fee program.

A new eight-month ANDA priority review pathway will be established as part of GDUFA II, the agency said in a Federal Register

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