Challenge #1: The Changing Regulatory Landscape
By 2030, 60 CGTs are expected to reach regulatory approval. One of the biopharmaceutical industry's most closely watched regulatory developments is the FDA’s reauthorization of the Prescription Drug User Fee Act (PDUFA) or PDUFA VII, as it provides resources for the FDA and CBER to have the capacity to provide feedback on development and review submitted applications, among other critical activities. During our Cell & Gene Live, Tackling Cell and Gene Therapies’ Top 3 Regulatory Impediments, Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO and Adora Ndu, PharmD, JD, Chief Regulatory Affairs Officer at BridgeBio break down how PDUFA VII, Fiscal Year 2023 Omnibus Appropriations Bill, and more will impact the cell and gene therapy field in the next few years.
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