Produce Safety Alliance, Critical Path Institute, and Loren A. Eng Recognized with Innovations in Regulatory Science & Policy Awards

(September 18, 2025) – The Reagan-Udall Foundation for the FDA will honor the Produce Safety Alliance, Critical Path Institute, and Loren A. Eng with its Innovations in Regulatory Science & Policy Awards on December 9, 2025. These awards recognize outstanding contributions to regulatory science and public health in three categories: Leadership, Innovation, and Advocacy/Policy.

“We look forward to celebrating this year’s awardees,” said Richard L. Schilsky, MD, FASCO, Chair of the Foundation’s Board of Directors. “Each has played a vital role in advancing regulatory science and enhancing public health and safety.”

The 2025 Leadership Honoree is the Produce Safety Alliance (PSA), a collaborative initiative between Cornell University, the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture. The PSA has played a pivotal role in developing and delivering science-based education, outreach, and training programs that help growers, regulators, and industry implement the FDA Food Safety Modernization Act’s Produce Safety Rule. Its efforts have transformed produce safety practices nationwide, supporting both public health and agricultural communities.

The 2025 Innovation Honoree is the Critical Path Institute (C-Path), an independent, nonprofit organization established in partnership with the FDA. Through innovative data-sharing consortia and pioneering methodologies, C-Path accelerates the development and regulatory review of medical products. Its groundbreaking work has led to the creation of novel drug development tools, improved trial designs, and informed more efficient regulatory pathways, directly advancing patient access to safe and effective therapies.

The 2025 Advocacy/Policy Honoree is Loren A. Eng, President of the Spinal Muscular Atrophy (SMA) Foundation. As a dedicated patient advocate and nonprofit leader, Eng has transformed the landscape of rare disease drug development through strategic collaborations with regulators, researchers, and industry. Her advocacy has not only advanced SMA research and treatment options but also reshaped regulatory policy approaches that benefit the broader rare disease community.

"Our 2025 honorees exemplify vision and innovation, and their work is already making a lasting difference in the lives of individual Americans—by enhancing the safety of fresh produce, improving the efficiency of developing new treatments, and assuring the patient is at the center of product development," said Susan C. Winckler, RPh, Esq., Foundation CEO. "We are excited to celebrate their accomplishments and impact."

The 2025 Innovations in Regulatory Science & Policy Awards dinner will be held on December 9 at the Willard InterContinental Hotel in Washington, DC. To learn more, visit www.reaganudall.org.