Woodcock's Prophesy Comes True: US FDA ANDA Approvals Decline From Record Levels
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.
You may also be interested in...
Talks between US FDA and industry to extend the generic drug and prescription drug user fee programs may last into 2021.
Productivity remains high as full ANDA approvals reached a FY 2020 peak and complete responses dropped to another low in June.
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.