ARTICLE | Regulation
FDA tweaks formula to avoid another user-fee spike
Application fee set to increase to $4.3M, would have been $5M using old formula
July 30, 2024 9:06 PM UTC
In the face of pressure from industry, FDA has modified its formula for calculating PDUFA application fees, avoiding a repeat of last year’s 25% increase.
The new formula resulted in a $4.3 million fee for applications that include clinical data, a 6.45% increase from FY24 to FY25. ...