The U.S. Food and Drug Administration (FDA) published a revision of its final guidance on “Application User Fees for Combination Products,” replacing guidance of the same name from 2005. The revision ...
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 ...
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 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 ...
The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2023 from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices. The table ...
MORGANTOWN, W.Va. — A bill that started as an effort to exempt state workers from municipal user fees has moved to a full repeal for all user fees following the approval of an amendment this week at ...
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 ...
Gas tax revenues are dwindling as cars become more fuel efficient and more drivers switch to electric vehicles. That revenue has been the primary source of state transportation funding for decades.
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