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Will GDUFA III Curtail Priority Assessments?

 
• By Derrick Gingery

US FDA's expedited pathway for generics seems to provide more benefits for amendments than for original ANDAs.

FDA entrance sign 2016

BALTIMORE – The US generic industry may consider limiting the kind of original ANDAs eligible for FDA's priority assessment pathway when the generic drug user fee is renewed again, in part because the speedier assessment seems more valuable for ANDA amendments.

Scott Tomsky, Teva Pharmaceutical Industries Ltd. VP of North America generics regulatory affairs, said Sept. 6 following a session...

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