Biotechnology Innovation Organization (BIO) Senior Vice President of Science & Regulatory Affairs Annetta Beauregard issued the following statement on the release of the Prescription Drug User Fee Act (PDUFA) VIII commitment letter: “For more than 30 years, PDUFA has helped deliver hundreds of new medicines to American patients. As a lead industry negotiator for the PDUFA VIII agreement, BIO supports the PDUFA VIII commitment letter and its strengthening of regulatory review, advancing innovation, and helping deliver safe and effective treatments to patients. “Specifically, the PDUFA VIII agreement includes important commitments that bolster the FDA’s core review activities, ensure accountability for predictable performance, improve financial sustainability and improve communication, transparency and efficiency. “Timely, bipartisan reauthorization of PDUFA is vital for protecting the health of Americans, strengthening U.S. competitiveness, and maintaining America’s global leadership in medical innovation. BIO is committed to working with Congress to ensure reauthorization by September 30, 2027.” The FDA has announced plans to hold a hybrid public meeting at 9am on 9/16 to discuss the proposed enhancements for the reauthorization of PDUFA for fiscal years (FYs) 2028 through 2033. Learn More about PDUFA and the PDUFA VIII commitment letter HERE .