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 […]
Read more March 21, 2022 – Pros and cons of the FDA’s accelerated approval pathway took center stage at a House Energy and Commerce Committee meeting held last week. While a slate of health-related bills for possible inclusion in the Prescription Drug User Fee Act (PDUFA VII) reauthorization package were discussed, the hearing led off with arguments […]
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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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 […]
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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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