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.
The FDA will increasingly use accelerated approval for gene therapies aimed at rare conditions, according to Peter Marks, the FDA’s top official overseeing cell and gene therapies, the clearest signal yet of how widely the agency will deploy its expedited pathway.
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.
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.
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.
Officials with the Food and Drug Administration (FDA) recently joined scientists at a public meeting on next steps for conducting research to develop psychedelic medicines.
We, as a society, are past the point of vaping being a new trend. It is now an epidemic for our young people with unfortunately no end in sight if we don’t take action now.
The Reagan-Udall Foundation, a non-profit created to advance the work of the U.S. Food and Drug Administration, held a two-day conference this week on current psychedelic research and clinical study design.
The U.S. Food and Drug Administration (FDA) together with the Reagan-Udall Foundation for the FDA are hosting a virtual public meeting on psychedelic research, Jan. 31 to Feb. 1.
Titled "Advancing Psychedelic Clinical Study Design," the event aims to explore "empiric approaches to address key issues in psychedelic drug development and research."
It is well to be noted that a proposed FDA reorganization might as well have food safety first and foremost; however, stakeholders throughout industries will go on to feel the effects of what Michael Rogers, associate commissioner for regulatory affairs, called the largest reorganization in the history of the FDA.
