![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » BsUFA Fees to Surge for Fiscal 2017
BsUFA Fees to Surge for Fiscal 2017
![](https://www.fdanews.com/ext/resources/test/Device_Images3/moneyinhand.gif?t=1435858774&width=430)
Biosimilar user fees under BsUFA will climb across the board starting Oct. 1.
Fees for BLA filings requiring clinical data in fiscal 2017 will increase $168,050 to $1.19 million while those without clinical data will rise $336,100 to $2.37 million.
The FDA’s announced fee schedule also shows supplemental filings that incorporate clinical data will climb to $1.02 million, while a supplement requiring clinical data will be double that: $2.04 million.
Product fees and establishment fees also saw an uptick, with product fees rising $16,700 to $114,450 and establishment fees rising $73,000 per establishment to $585,200.
Upcoming Events
-
21Oct