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 May 17, 2022 – Considering that the Food and Drug Administration (FDA) receives nearly half of its funding from medical product user fees, the timely reauthorization of user fees before the current iteration expires Sept. 30 is paramount to ensuring smooth product review operations. But this “must-pass” legislation opens the door to additional priorities and […]
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Jan. 24, 2022 – With the COVID-19 pandemic heading into year three, the Food and Drug Administration (FDA) faces ongoing challenges but continues to work on four primary agency priorities, according to Nancy Bradish Myers, president of Catalyst Healthcare Consulting, who spoke at a Jan. 21 Coalition for Healthcare Communication webinar, “A New Start for […]
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 […]
Read more Aug. 7, 2017 – In a 94-1 vote, the U.S. Senate on Aug. 3 passed FDA user fee reauthorization legislation that will revise and extend the user fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products through 2022. H.R. 2430, the FDA Reauthorization Act of 2017, was passed by the House […]
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