(August 17, 2022) The Reagan-Udall Foundation announced today that former Commissioner of Food and Drugs Jane E. Henney, MD, and former FDA Chief of Staff Lauren Silvis, JD, will lead the operational evaluation of the Food and Drug Administration’s human foods and tobacco work. Henney will lead the evaluation team focused on human foods while Silvis will lead the team focused on tobacco. The project was announced by Commissioner Robert Califf late last month. 

(April 4, 2022) The Reagan-Udall Foundation for the FDA (FDA Foundation) seeks nominations for its annual Innovations in Regulatory Science Awards. These awards recognize outstanding contributions made by individuals or organizations in the field of regulatory science.  

The Awards will be presented in three categories. Full nomination criteria and submission guidelines are available on the Foundation website.  

What: The Reagan-Udall Foundation for the FDA (FDA Foundation), in collaboration with the U.S. Food and Drug Administration, is hosting a virtual public meeting to explore questions about access to naloxone, a drug used to reverse opioid overdoses. Harm reduction specialists, physicians, pharmacists, and regulators will share their experiences in addressing the availability of this life-saving medication for heroin, fentanyl, and prescription opioid overdose. Significant time is set aside to allow public comment for up to 30 people (pre-registration required).

(March 7, 2022) The Reagan-Udall Foundation for the FDA (FDA Foundation) has appointed four new members to our Board of Directors: 

(March 1, 2022) The Reagan-Udall Foundation for the FDA (FDA Foundation) awarded $1.8 million in funding for two research projects evaluating the Real-World Performance of In Vitro Diagnostics (PIVD). Beth Israel Deaconess Medical Center will receive $898,045 to study antigen and molecular COVID-19 tests using real-world patient data. IDx20 will receive $893,500 to compare the performance of COVID-19 antigen tests in clinical settings versus real-world data collection. Their project includes a coalition of teams from the City of Chelsea, MA.  

(February 4, 2022) The Reagan-Udall Foundation for the FDA, at the request of the U.S. Food and Drug Administration, has released a report that outlines initial lessons learned from the federal government’s and research communities’ COVID-19 response and provides actionable recommendations to enhance the scope, prioritization, and communication of research activities within the context of a public health emergency. The report can be viewed here.

The Reagan-Udall Foundation for the FDA is pleased to announce the availability of funds to support studies of the real-world performance of two types of COVID-19 diagnostic tests. The purpose of this research is to evaluate real-world performance for two types of diagnostic tests (antigen and molecular) and to determine how RWD/RWE can be leveraged for Emergency Use Authorizations (EUA) or full market approvals (FMA).

(September 27, 2021) The Reagan-Udall Foundation for the FDA will present 2021 Innovations in Regulatory Science Awards to Peter Marks, MD, PhD, The COVID-19 Research Database, and former U.S. Representative Patrick J. Kennedy.  

(June 3, 2021) The Reagan-Udall Foundation for the Food and Drug Administration (FDA Foundation) is expanding its leadership with the addition of two new Board members: Christie Boutte, PharmD, RPh, Senior Vice President of Reimbursement, Innovation, and Advocacy for the National Association of Chain Drug Stores (NACDS) and Phil Febbo, MD, Chief Medical Officer for Illumina.