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.
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The revenue is expected to sustain the prescription drug user fee program moving forward after reserves were tapped at the start of fiscal year 2023.
Approval and submission data indicate steady trends aside from one outlier year.
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.