Announcements

The Reagan-Udall Foundation for the FDA has received funding from The Rockefeller Foundation to support the COVID-19 Diagnostics Evidence Accelerator launched earlier this year in collaboration with Friends of Cancer Research. As a science-driven…
Submitting expanded access requests to FDA just got easier for physicians. The Reagan-Udall Foundation for the FDA, with input from experts at FDA, today launched Expanded Access eRequest to streamline expanded access for individual patients in non-…
The following quote is attributed to Harpreet Singh, M.D., Associate Director, Cancer in Older Adults and Special Populations, FDA’s Oncology Center of Excellence; and Director, Division of Oncology 2, FDA’s Center for Drug Evaluation and Research:

Coverage

Extraordinary and unusual measures may be needed to rapidly develop and distribute a vaccine against SARS-CoV-2, but those efforts should not compromise the safety and efficacy of any product that reaches the market, according to the FDA Vaccines and…
Concerns raised yesterday by an advisory group to the U.S. Food and Drug Administration (FDA) may once again tap the brakes on Operation Warp Speed, the U.S. government’s $10.8 billion push to rapidly move candidate COVID-19 vaccines from concept to…
Executive Summary CDC officials designing distribution plans worry some eligible for vaccination may wait for a better product to emerge. Federal officials are now confronting another challenge for the uptake of a potential coronavirus vaccine –…