Academics and pharmaceutical/biotech companies are now interested in developing the psychedelic products for therapeutic uses in treating diseases like major depression, PTSD, Pakington's disease,...
In order to obtain the regulatory approval, various phases of clinical trials need to be conducted. The clinical trial designs for psychedelic drugs are more complicated than typical drugs because of its known side effects and the nature of the substance-controlled products.
Reagan-Udall Foundation recently organized a virtual public meeting to discuss "advancing psychedelic clinical study design". During this public meeting, attendees discussed the experience of scientists working with psychedelics in FDA-authorized clinical studies and drug development, considerations for psychedelics in clinical trial designs, and perspectives and current research in psychedelic clinical trials. FDA presenters provided an overview of its newly issued guidance "Psychedelic Drugs: Considerations for Clinical Investigations."
Video recording of this virtual public meeting is available on Reagan-Udall Foundation website: