Amy L. McGuire, Holly Fernandez Lynch, Lewis A. Grossman,, I. Glenn Cohen; Science
This article discusses the regulatory challenges faced in the development of psychedelic medicine. It highlights the growing interest, investment in psychedelic drug development, the complexities of applying traditional clinical trial, premarket approval processes to these substances. The article emphasizes the need for regulatory creativity, collaboration to maximize the therapeutic potential of psychedelics, considering their use outside the medical establishment, the limited evidence on their clinical benefits.