Announcements

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…
(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…
(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…

Coverage

On February 21, the Biotechnology Innovation Organization’s (BIO) soon-to-be CEO, John F. Crowley, joined an event about biomarkers and rare disease regulatory pathways, hosted by the Reagan-Udall Foundation for the Food and Drug Administration in…
Flexible thinking and rigorous standards will both be needed to develop psychedelics as drug therapies in order to surmount the many complicating factors, from unique ‘set and setting’ aspects to functional unblinding, speakers at Reagan-Udall…
Even as FDA stands by its decision that CBD is not safe for use in foods, beverages and dietary supplements, the agency is considering how best to ensure it is clearly labeled, safely manufactured and consumers understand what it is, according to a…