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 ...
As outlined in Akin Gump’s previous analysis, the current five-year authorization of the Food and Drug Administration (FDA) user fee programs for branded/reference drugs and biologics, medical devices ...
The US Food and Drug Administration (FDA) on Tuesday announced that it will gather information on creating a new user fee program for nonprescription, over-the-counter (OTC) drugs. But unlike ...
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 ...
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 ...
Sen. Richard Burr (R-N.C.) on Thursday said the five-year reauthorization of the Food and Drug Administration’s (FDA) user fee program will be included in the stopgap spending bill meant to prevent a ...
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