RPI Blog PDUFA VII: Implications for Developers of Cell and Gene Therapies

One of the biopharmaceutical industry's most closely watched forthcoming regulatory developments is the FDA's imminent reauthorization of the Prescription Drug User Fee Act (PDUFA). PDUFA VII, as the reauthorization is commonly known, will cover the fiscal years 2023-2027. Many of the advancements included in PDUFA VII are driven in large part by an increase in the development of innovative products such as cell and gene therapies. This blog post addresses those aspects of PDUFA VII that are expected to affectRead moreThe post PDUFA VII: Implications for Developers of Cell and Gene Therapies appeared first on Regulatory Professionals.