With Increasing New Drug INDs Projected, How Much More Workload Can US FDA Handle?
Meanwhile, the biosimilars program is expecting essentially flat application numbers, but more manufacturing supplements and more development meetings, which likely is an indication of the sector’s flourishing in the US.
You may also be interested in...
US FDA's FY 2023 User Fees Finally Revealed
Several fees for prescription drug, generic drug, and biosimilar applications are set to increase, although some also will drop.
Will US FDA User Fee Deal Allow BsUFA Reg Science Research To Start?
The FDA had picked grantees for the initial round of biosimilar regulatory science research, but told them not to start major activities until the user fee reauthorization was assured. Congress now appears to have reached deal for a ‘practically clean’ reauthorization.
US FDA Plans Education Efforts As Humira Biosimilars Launch
Just-in-time education may be preferred, so patients and providers see it as they are making decisions, OTBB Director Sarah Yim says in an interview.