(October 11, 2024) Steven A. Grossman, JD; Jeff Shuren, MD, JD; and the Real-World Evidence Collaborative will receive the Reagan-Udall Foundation for the FDA’s 2024 Innovations in Regulatory Science Awards on December 10. The prestigious awards recognize outstanding contributions to regulatory science and public health in three categories: Leadership, Innovation, and Advocacy/Policy.  

“We are delighted to honor the remarkable contributions of this year’s awardees,” said Richard L. Schilsky, MD, FASCO, chair of the Foundation’s Board of Directors. “Their work inspires us, motivates us, and reminds us of the need to keep moving forward on all fronts of regulatory science.”

The 2024 Leadership Honoree is Jeff Shuren, MD, JD, Center Director Emeritus at the U.S. Food and Drug Administration. Prior to August 2024, Dr. Shuren was the Director of the Center for Devices and Radiological Health, a tenure marked by significant accomplishments that have modernized and improved medical device regulation in the United States. During his transformative career, he achieved a number of milestones, including a five-fold increase in new medical device authorizations in the U.S., establishment of key programs like the Breakthrough Devices Program and the Digital Health Center of Excellence, and notable contributions to the Medical Device Innovation Consortium and the International Medical Device Regulators Forum.

The 2024 Innovation Honoree is the Real-World Evidence (RWE) Collaborative. The RWE Collaborative launched the International Harmonization of RWE Standards Dashboard late last year to address a critical need for global alignment on real-world data and real-world evidence standards. This groundbreaking tool provides up-to-date summaries of international regulatory guidance and simplifies access to essential regulatory definitions, data quality standards, and relevant literature, promoting harmonization across global health priorities. The RWE Collaborative, convened by the Duke-Margolis Center for Health Policy, is comprised of multiple stakeholders  with a shared goal and interest in advancing real-world evidence policy.

The 2024 Advocacy/Policy Honoree is Steven A. Grossman, JD, recognizing his role as co-founder and Executive Director of the Alliance for a Stronger FDA. The Alliance, established in the mid-2000s, advocates for a unified increase in FDA funding across all sectors, emphasizing the critical role the FDA plays in food and medical product safety. Grossman’s efforts contributed to a doubling of the FDA’s budget, helping the agency manage new challenges such as evolving scientific complexity, medical software, AI regulation, and food safety. Comprised of patient groups, industry, and consumer advocates, the Alliance’s educational programs have increased policymaker and public understanding of the FDA's expanding mission, growing responsibilities, and budget process.

“The vision and innovation of our 2024 honorees is inspiring and their work has—and will continue to have—lasting impact,” said Susan C. Winckler, RPh, Esq., CEO of the Reagan-Udall Foundation for the FDA. “We look forward to celebrating their achievements.”

The 2024 Innovations in Regulatory Science Awards dinner will be held at the Willard InterContinental Hotel in Washington, DC, on December 10. To learn more or register for the event, please visit www.reaganudall.org.