Announcements

(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.…
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…

Coverage

When the U.S. Food and Drug Administration made the opioid overdose reversal drug naloxone an over-the-counter medication last summer, health care advocates praised the removal of the prescription barrier as an effective tool to prevent fentanyl deaths…
At Denali Therapeutics, where I serve as chief medical officer and head of development, we are eager to develop new treatments for progressive and debilitating neuronopathic mucopolysaccharidoses diseases with our novel technology. We are not alone—…
A meeting convened by the Reagan-Udall Foundation for the FDA on qualifying rare disease biomarkers for accelerated approvals could be an inflection point for patients with ultrarare diseases, their families, biotech companies, and FDA. Read more