Aug. 30, 2022 – When members of the House and Senate return to Washington Sept. 6 following the Labor Day holiday, they face competing priorities and tight timeframes to take action on the federal budget and user fees, which expire on Sept. 30. Failure to pass the fiscal year 2023 (FY 2023) budget and reauthorize […]
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July 18, 2022 – With just days left before a deadline to send layoff notices to thousands of Food and Drug Administration (FDA) staff, legislation to reauthorize prescription drug user fees – which fund half of the FDA’s budget – has not yet been passed. Although Congress is well aware of both the Sept. 30 […]
Read more Feb. 14, 2022 – Negotiations for prescription drug and medical device user fee legislation are running behind schedule and legislators are concerned about the timeline for the Prescription Drug User Fee Amendments VII (PDUFA VII), the Medical Device User Fee Amendments (MDUFA) and other user fee bills. Because the Food and Drug Administration (FDA) receives […]
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Oct. 11, 2021 – The Food and Drug Administration (FDA) will hold a virtual public meeting Nov. 2 to discuss the proposed changes it would like to make during the reauthorization process for the Biosimilar User Fee Act for fiscal years 2023 through 2027 (BsUFA III). The current legislation, BsUFA II, will expire in September […]
Read more Sept. 10, 2021 – The Food and Drug Administration (FDA) recently issued a commitment letter regarding the next iteration of the Prescription Drug User Fee Act (PDUFA VII) that spells out its review timeframes, performance goals and modernization priorities for fiscal years (FYs) 2023-2027. Among these priorities are enhancements related to expediting drug development, expanding decision […]
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