Steven A. Grossman, Jeff Shuren, and the Real-World Evidence Collaborative Recognized with Innovations in Regulatory Science Awards

(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.  

ASH Research Collaborative and Reagan-Udall Foundation for the FDA Launch Sickle Cell Disease Real-World Data Project

(WASHINGTON, April 17, 2024) –The ASH Research Collaborative (ASH RC) and the Reagan-Udall Foundation for the Food and Drug Administration (FDA Foundation) are launching the Real-World Evidence Consortium for Sickle Cell Disease (SCD) to develop consensus recommendations on clinical outcomes important to treating people with SCD and apply those standards to real-world data sets. The goal of the Consortium is to improve the lives of individuals living with SCD through real-world evidence generation and cutting-edge research. 

Reagan-Udall Foundation for the FDA Announces New Board Leaders, Members

(March 6, 2024) The Reagan-Udall Foundation for the FDA has announced new officers and two new members of its Board of Directors. 

Adrian F. Hernandez, MD, MHS, a Board member since 2019, has been elected to serve as the Board’s Vice Chair. Debra L. Ness, MS, on the Board since 2022, assumes the role of Treasurer. Lynne Zydowsky, PhD, a Board member since 2019, is the board’s new Secretary. 

Reagan-Udall Foundation for the FDA Announces Hybrid Public Meeting on Qualifying Biomarkers to Support Rare Disease Regulatory Pathways

What: The Reagan-Udall Foundation for the FDA will host a public workshop to explore primary disease activity biomarkers in rare genetic diseases.  Attendees will hear perspectives from patient advocates, researchers, regulators, and representatives from regulated industry.  The discussions will include a series of case studies (heparan sulfate in neuronopathic lysosomal storage diseases) and a dialogue on the challenges in qualifying biomarkers to support rare disease approvals. 

 

Dr. Francis Collins, FDA’s GenomeTrakr, and Representative Diana DeGette and former Representative Fred Upton Recognized with Innovations in Regulatory Science Awards

(December 4, 2023) The Reagan-Udall Foundation for the FDA will present Innovations in Regulatory Science Awards to Francis Collins, MD, GenomeTrakr, and jointly to Representative Diana DeGette (D-CO) and former Representative Fred Upton (R-MI) on December 5, 2023. The awards recognize outstanding contributions to regulatory science and public health in three categories: Leadership, Innovation, and Advocacy/Policy.  

Reagan-Udall Foundation for the FDA Names 2023-24 Fellow in Regulatory Science, Innovation, and Health Equity

(August 15, 2023) The Reagan-Udall Foundation for the FDA has selected Kendra Getaw, PharmD, as its 2023-24 Fellow in Regulatory Science, Innovation, and Health Equity. Her year-long role, which began July 2023, includes activities across the Foundation.

Reagan-Udall Foundation for the FDA Announces New Board Leadership, Members

(February 7, 2023) The Reagan-Udall Foundation for the FDA (FDA Foundation) has announced new officers and members of its Board of Directors. 

Richard L. Schilsky, MD, FACP, FSCT, FASCO, has been elected to a three-year term as Chair of the FDA Foundation Board of Directors. Georges C. Benjamin, MD, assumes the role of Vice Chair. Allan Coukell, BScPharm, continues his service as Secretary/Treasurer. 

 Three new members have been appointed to the FDA Foundation Board for a four-year term: 

Expert Panel Submits Operational Evaluation of FDA’s Tobacco Program to Commissioner

(December 19, 2022) The Independent Expert Panel for Tobacco today submitted its recommendations to Commissioner Robert Califf at the U.S. Food and Drug Administration. The Operational Evaluation of Certain Components of FDA’s Tobacco Program was facilitated by the Reagan-Udall Foundation at the Commissioner’s request.