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.
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 from regulated industry. The discussions will include a series of case studies (heparan sulfate in neuronopathic lysosomal storage diseases) and a dialogue on the challenges in qualifying biomarkers to support rare disease approvals.
