FDA may soon approve its first psychedelic drug, raising questions about regulation, treatment settings and who may administer it

The FDA may approve its first psychedelic drug as early as next year after the Trump administration moves to fast-track applications for several psychedelic treatments. The prospect of approval raises unresolved regulatory questions, including who should be permitted to administer these treatments, who should be allowed to receive them, and which settings would be appropriate. The FDA would need to establish rules governing both access and delivery before or alongside approval. The supplied material does not identify a specific psychedelic, describe the proposed treatment protocols, or explain how the agency would balance clinical access, safety, and oversight.