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How biomarkers can support regulatory rare disease pathways - BioNews
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 Washington, D.C.
Natural History Studies and Registries in the Development of Rare Disease Treatments
The Reagan-Udall Foundation for the FDA, in collaboration with FDA’s Rare Diseases Team within the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine; Office of New Drugs; Center for Drug Evaluation and Research and the National Institutes of Health’s Division of Rare Diseases Research Innovation within the National Center for Advancing Translational Sciences, is hosting a public workshop.
For Psychedelics, US FDA Is Open To Creative Thinking But Firm On Approval Standards - Pink Sheet Citeline
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 Foundation meeting agree.
FDA tackles safety challenges related to ‘misinformation’ about CBD, food additives and how it makes science-based decisions - Nutra Ingredients
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 senior agency official.