US FDA Talking Tough On ANDAs, Says Extensions On Complete Responses Need Justification
But most generic sponsors already give reasons for needing more time to respond to a complete response letters, so the status quo may not change despite the new guidance.
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User Fee Renewal Negotiations Beginning This Week
Talks between US FDA and industry to extend the generic drug and prescription drug user fee programs may last into 2021.
Generic Association’s New CEO Signals Focus On Communications
Dan Leonard’s communications background, in addition to his policy expertise, may prove useful for the Association for Accessible Medicines as it navigates ongoing market and public policy challenges.
Teva’s Rx For GDUFA III: Treat Complex Generics More Like NDAs
New drug review elements that could benefit complex generics include a two-month filing review period before the user fee clock is triggered, more interaction between the agency and a sponsor during the review, and an opportunity for a company to have in-depth discussions with the FDA after receipt of a complete response letter, Teva’s Scott Tomsky says at kick-off meeting for next iteration of the generic drug user fee agreement.