FDA Slashes Biosimilar Development Program Fees For Fiscal 2021

FDA plans to reduce fees for its biosimilar product development (BPD) program in fiscal 2021 and to keep overall biosimilar user fee program and application fees at their fiscal 2020 levels, the agency announced Thursday (July 30). Though the agency estimates it will need about 27 additional full-time equivalents in fiscal 2021, it will not need extra money to fund the FTEs, FDA adds. “FDA determined that the realistic expected net FTE gains could be funded through the expected FY...