Generic Drug Approvals Still Winning The Pandemic At US FDA
Productivity remains high as full ANDA approvals reached a FY 2020 peak and complete responses dropped to another low in June.
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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.
Biosimilar development programs also are expected to increase, a promising sign for the growing sector, but those fees remained unchanged.
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.