A More Perfect Meeting: Industry Seeks Additional PDUFA VII Metrics To Improve Communications
Will the US FDA agree to more structured communications amid its struggles with the existing meeting workload?
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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.