Diagnostics Lab Meeting

 Professor Mara Aspinall of the Diagnostic Commons housed at Arizona State University will join us to reflect on the past, present and future of diagnostic tests. Matthew Gee of Siemens will take a look at lessons learned from using real-world data in regulatory submissions for COVID diagnostics tests. Carla Rodriguez-Watson will provide a preview of the Real-World Accelerator to evolve the standard of Care and Engagement (RACE) for communities of color.

FDA Voices: FDA's Overdose Prevention Framework Aims to Prevent Drug Overdoses and Reduce Death

In 2021, a record number of Americans – more than 107,000 – died from drug overdoses. While the loss of human life alone is staggering, we know that the effects of the drug overdose crisis are even broader, including enormous individual and societal costs as people and families grapple with substance use disorder (SUD). Due to this unfortunate reality, in 2017 the opioid crisis was determined to be a public health emergency, which to this day is still in effect. Today’s drug overdose crisis is multifaceted and has evolved beyond prescription opioids.

Experts Announced for Review of FDA Human Foods Program

(September 1, 2022) The Reagan-Udall Foundation today announced five members of an Independent Expert Panel who will conduct the operational evaluation of the Food and Drug Administration’s human foods program. Dr. Jane Henney, former FDA Commissioner, was named as Chair of the panel last month. Joining Henney are Francisco Diez-Gonzalez, James Jones, Barbara Kowalcyk, Shiriki Kumanyika, and John Taylor.

COVID-19 Evidence Accelerator: What We've Learned, Where We're Headed

In the midst of a global pandemic, the Reagan-Udall Foundation for the FDA, along with Friends of Cancer Research, created an unprecedented regulatory science collaborative to share real-world data and to generate innovative responses on how to deal with COVID-19. 

On October 20, 2022, we highlighted the accomplishments and shared learnings from more than 200 meetings, and 275 expert presentations, including how best to leverage real-world data and improve data interoperability to address current and future health challenges.