FDA Hosts Public Psychedelics Discussion, Discloses Major Growth On Number Of New Psychiatric Drugs Filings Post-2000
FDA and Reagan-Udall Foundation are hosting a virtual public meeting on psychedelic research titled Advancing Psychedelic Clinical Study Design, which aims to explore empirical approaches to address issues in drug development.
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.”
In June 2023, the federal agency issued its first draft guidance providing general considerations to industry sponsors developing psychedelic drugs for the treatment of medical conditions. The document was commented on, among others, by specialized lawyer Mason Marks.
While the guidance highlights some considerations for designing psychedelic clinical trials to optimize the interpretation of results, several questions remain regarding the most appropriate way to address such challenges.
Also Read: State-Regulated Psychedelics ‘On A Collision Course’ With FDA, Says Harvard Law Expert
The meeting will …