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Treat Complex Generics More Like NDAs In GDUFA III, Teva Says

As GDUFA III Virtual Public Meeting Kicks Off

Executive Summary

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.

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