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 […]
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Nov. 30, 2018 – The 2018 midterm elections resulted in a divided Congress, questions about possible agency changes, and uncertainty related to drug pricing policy and the Affordable Care Act, according to Kate Rawson, senior editor, Prevision Policy and The RPM Report, who spoke at the Coalition for Healthcare Communication’s “2018 Post-election Conference on Healthcare […]
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