Psychedelic Drugs: Regulators Still Unsure On Development Path, But Willing To Listen

Potential sponsors have many questions to answer, but have a unique opportunity to influence policy for a new therapy area.

mushrooms — An EMA official said sponsors may have to think out of box in designing psychedelic clinical trials. • Source: Shutterstock

Psychedelic drug development may no longer be impossible or unlikely, but basic clinical questions still must be answered to help unleash the sector’s growth.

After decades on Schedule I, the US Food and Drug Administration and other regulators have recognized that psychedelics like LSD may have clinical benefits. Guidance now is available to help...

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