The House of Representatives recently passed a short-term continuing resolution (CR), HR 6833, as a temporary stopgap measure to continue funding the United States government past the end of the ...

Based on what was agreed to under the Biosimilar User Fee Amendments (BsUFA III), FDA estimated that its base revenue from the program for FY 2027 needs to bring in $58,926,749 before being adjusted ...

While inflation in the U.S. is hovering below 3%, increases in some FDA user fees for fiscal 2026 are tripling that rate. PDUFA fees for branded prescription drugs and biological products will see a 9 ...

If the FDA charged food companies user fees it could strengthen its oversight of food safety, according to a recent study. The study, “Advancing the FDA’s Human Foods Program Through Additional ...

The Food and Drug Administration (FDA) human medical product user fee programs, covering prescription drugs (PDUFA), medical devices (MDUFA), generic drugs (GDUFA) and biosimilars (BsUFA), are ...

A research team at New York University has come up with a way to fund FDA food programs, including food safety, without using government money. The team suggests that user fees be implemented — as ...

A vague and somewhat perplexing provision buried in President Donald Trump’s budget blueprint would double FDA user fees, placing a new burden on the digital health industry—particularly smaller ...

As Congress works to reauthorize for the seventh time pharmaceutical user fee legislation, it is overlooking what should be part of virtually every law that affects industry these days: the climate ...