Teva’s Rx For GDUFA III: Treat Complex Generics More Like NDAs
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.
You may also be interested in...
Janet Woodcock’s 2019 prediction that record ANDA approval volumes would not continue is confirmed with the FY 2020 approval total down 21% from the previous year.
Complex active ingredients, formulations, routes of delivery, and drug-device combination products are to receive greater attention as part of attempts to facilitate competition after the US FDA awarded a $5m grant to establish a dedicated research center.
The FDA has published fresh guidance taking a tougher stance on sponsor reasons for needing more time to respond to complete response letters.