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. 

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. 

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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."