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Some Boston-area researchers said the decision by advisors to the U.S. Food and Drug Administration reflected challenges facing regulators as psychedelic treatments enter mainstream psychiatry.
Psychedelic-assisted therapy is poised to move from the research setting to clinical practice, and a group of experts offer seven essential elements of informed consent for psychedelic therapy.
MAPS Public Benefit Corp. is seeking FDA approval of MDMA in combination with therapy to treat PTSD, in what would be the first treatment of its kind.
The Food and Drug Administration (FDA) says it will consider approval of psychedelic drug MDMA to be used in therapy for post-traumatic stress disorder (PTSD). If FDA approves the drug, also known as ecstasy, it would mark the first psychedelic-assisted therapy approved for PTSD and follows more than 30 years of clinical research, according to…
A new article authored by renowned regulatory specialist Dr. Mason Marks, of the Project on Psychedelics Law and Regulation at Harvard Law School, highlights growing concern about the chasm between state-level regulations and the FDA’s stance on psychedelics.