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Teva’s Rx For GDUFA III: Treat Complex Generics More Like NDAs

 
• By Sue Sutter

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.

Silhouette of diving board at sunset
FDA and industry want to use the successes of GDUFA II as a springboard to a new generic drug user fee agreement. • Source: Shutterstock

The third iteration of the generic drug user fee agreement should incorporate elements from the new drug review side to increase regulatory predictability, review transparency and the first-cycle approval rate for complex generics, Teva Pharmaceutical Industries Ltd. believes.

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