Steven Schain of Smart-Counsel LLC. FDA's Psychedelic Drug Clinical Trial Guidance Aims to Stimulate Funding, Acceptance
Forming the federal government's first directive on how to research psychedelics' medical application, the guidance removes this multibillion dollar industry's two major stumbling blocks: public acceptance and funding.
August 25, 2023 at 11:33 AM
7 minute read
Providing critical tools for investigating psychedelics use in treating medical conditions, the U.S. Food and Drug Administration (FDA) issued "Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry" (guidance) in June 2023.
Ranging from plant drugs, like mushroom-derived psilocybin and cactus-derived peyote, to synthetics like Lysergic acid diethylamide (LSD) and Methylenedioxymethamphetamine (MDMA), hallucinogens are increasingly used to treat recognized disorders, including depression, anxiety, and post-traumatic stress disorder (PTSD), and for wellness applications like enhancing emotional empathy, increasing feelings of closeness and promoting thoughtfulness and contemplativeness.
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