FDA Increases Generic Application Fees, Lowers Others, For Fiscal 2021

FDA will increase its generic drug user fee application and drug master file fees in fiscal 2021 while reducing overall generic program and facility fees across the board, the agency announced Friday (July 31). A former FDA official said the lower program and facility fees are likely due to an uptick in new generic drug firms. Fees for drug master files experience the biggest percentage increase, rising from $57,795 in fiscal 2020 to $69,921 in fiscal 2021 for a 21%...