GDUFA III May Rely Less On PDUFA As A Role Model
Meeting opportunities codified in GDUFA II were adapted from the new drug user fee program experience but may not be well suited to the commodified generic drug industry built on volume and speed, industry representatives said at the recent FDLI annual meeting.
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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.
Amid questions about generic industry market dynamics, the user fee renewal could focus on limiting increases in US FDA collections.
US FDA and complex generic sponsors need a way to talk about reference product and other changes once the pre-submission meetings pathway is exhausted.