FDA issues draft guidance for clinical research into psychedelics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decent capital investments and started testing the efficacy of their treatments, and now the FDA has released a draft guidance on conducting clinical research into psychedelic drugs like psilocybin.
The draft guidance, which was published Friday, states that the psychedelics in question include compounds such as psilocybin and LSD, as well as drugs such as MDMA.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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