FDA issues draft guidance for clinical research into psychedelics

Sev­er­al star­tups study­ing psy­che­delics have re­ceived de­cent cap­i­tal in­vest­ments and start­ed test­ing the ef­fi­ca­cy of their treat­ments, and now the FDA has re­leased a draft guid­ance on con­duct­ing clin­i­cal re­search in­to psy­che­del­ic drugs like psilo­cy­bin.

The draft guid­ance, which was pub­lished Fri­day, states that the psy­che­delics in ques­tion in­clude com­pounds such as psilo­cy­bin and LSD, as well as drugs such as MD­MA. It ac­knowl­edges the grow­ing pres­ence of psy­che­del­ic drug tri­als, and it states that de­sign­ing clin­i­cal stud­ies to eval­u­ate the safe­ty and ef­fec­tive­ness of these drugs for med­ical con­di­tions “presents sev­er­al unique chal­lenges.”

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