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US FDA Outlines Psychedelic Drug Trial Principles, But It Won’t Be An Easy Trip

 
• By Michael McCaughan and Laura Helbling

The US FDA is offering its first formal advice for potential approaches to develop psychedelic drugs for therapeutic indications. But it won’t be easy.

psychedelic drugs
Among the recommendations in the FDA's new psychedelic drugs guidance is that a REMS could be imposed with approval. • Source: Shutterstock

The US Food and Drug Administration is acknowledging the emerging interest in exploring therapeutic uses of psychedelic drugs, but does not sound overly “psyched” about the prospects.

The agency released draft guidance in late June offering its initial thinking on clinical development of psychedelic drugs. The guidance is a milestone in recognizing the burgeoning interest in exploring potential therapeutic applications of products like LSD, psilocybin and MDMA

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