Stakeholders call on FDA to set safety and treatment standards for emerging psychedelic therapies

At a recent public hearing, experts and other stakeholders emphasized the need for clear safety and access guidelines as psychedelic medicines move closer to market.

The FDA is intensifying efforts to create a regulatory framework for these therapies, and participants urged the agency to define data requirements and treatment standards.

Analysts described the overall tone as constructive, though some specialists called for stronger risk assessment and adverse event monitoring as part of any approval process.

Two developers are nearing pivotal milestones: Compass Pathways expects its psilocybin depression drug COMP360 to launch early next year, while Definium Therapeutics reported a third Phase 3 success for its oral LSD candidate DT120, building on the earlier approval of Johnson & Johnson's esketamine product Spravato.