Biotechnology Innovation Organization (BIO) Chief Scientific Officer, E. Cartier Esham issued the following statement on the release of the Prescription Drug User Fee Act (PDUFA) VII performance goals letter:“The Prescription Drug User Fee Act (PDUFA) continues to enhance and strengthen the U.S. Food and Drug Administration (FDA) in fulfilling its public health mission and ensure that safe, effective, and high-quality new drugs and biological products are reviewed in an efficient and predictable time frame.“BIO is supportive of the newly-released PDUFA VII commitment letter. We believe it achieves our goals of strengthening scientific dialogue between FDA and industry as well as promoting innovation and a patient-centric review process.“BIO looks forward to working with the FDA, Congress, patient groups, and all other stakeholders to ensure timely reauthorization of the PDUFA package.”The PDUFA VII agreement achieves the following objectives:Strengthens scientific dialogue between FDA and Industry to promote innovationEnhances patient-centric drug review and supports the next wave of advanced biological therapies (i.e., cell and gene therapies)Modernizes regulatory and drug development tools, including advancing the use of real-world evidence for regulatory decision-makingAdvances digital technology tools and modernizes FDA’s information technology infrastructure, including the adoption of cloud-based systems and capabilitiesImproves innovation in manufacturing and quality, including lessons learned from COVID-19Enhances FDA hiring, retention, and financial management systemsThe FDA  is announcing a virtual public meeting to discuss the proposed enhancements for the reauthorization of PDUFA for fiscal years (FYs) 2023 through 2027.About BIOBIO is the premier biotechnology advocacy organization representing biotech companies, industry leaders, and state biotech associations in the United States and more than 35 countries around the globe. BIO members…