News

“One of the things that we’ve noticed, not just in the pandemic, is this problem of missing race and ethnicity information,” explained Carla Rodriguez-Watson, Ph.D., MPH, Director of Research at the Reagan-Udall Foundation for the FDA. “If you do not…

Ultragenyx Pharmaceutical's work to get the FDA to recognize a biomarker as a surrogate endpoint looks to have paid off. With the agency agreeing the biomarker is a reasonable surrogate endpoint, Ultragenyx is preparing to file for approval of its…

Medable Inc., the leading technology provider for modern clinical trials, today announced that the Partnership for Advancing Clinical Trials (PACT) consortium in conjunction with the Tufts Center for the Study of Drug Development (CSDD) has produced…

Soon there could be nutrition labels on the front of food packages at the grocery store — not just on the back or side. The Food and Drug Administration said the goal of potentially implementing this new label on prepackaged goods is to “help ensure…

The Food and Drug Administration is expected to propose a change to prepackaged food sold in America: a requirement that the front of the packages display key nutrient information in addition to the nutrition label that’s already on the back. Read more

Regular engagement with patients participating in registries is key to ensuring they continue to participate in long-term follow-up about a disease’s progression or the effectiveness of a treatment, leaders of patient advocate groups who have created…

FDA’s total request of $7.2bn for FY 2025, an increase of $341m from the FY 2024 numbers, “will allow the agency to continue to leverage new and emerging technologies,” and unite the Human Foods Program under “a single line of authority,” FDA…

This news that Reagan-Udall Foundation for the FDA and the ASH Research Collaborative have established a new Real-World-Evidence Consortium for Sickle Cell Disease which aims to "develop consensus recommendations on clinical outcomes important to…

WASHINGTON—House Committee on Oversight and Accountability Chairman James Comer (R-Ky.) today opened a hearing titled “Oversight of the U.S. Food and Drug Administration” to bring transparency to a pattern of issues within the U.S. Food and…