Treat Complex Generics More Like NDAs In GDUFA III, Teva Says
As GDUFA III Virtual Public Meeting Kicks Off
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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Generics industry and FDA also debated inspection policies in lieu of travel and safety restrictions mandated by the pandemic.
Forecasting up to a dozen complex generic launches by Teva in the US in 2021, executive vice-president for North America commercial Brendan O’Grady said Teva was continuing to push for changes to boost approval rates ahead of GDUFA III next year.
As GDUFA III negotiations continue, FDA doesn’t seem ready to make additional changes to approval process, but industry argues guidance practices and communications need fixing and that consumers are missing out on potential savings because of it.