In this episode of Psychiatry Tomorrow, Dr. Carlene MacMillan hosts a panel of experts to discuss the FDA's pending decision on MDMA-assisted therapy for PTSD. The conversation explores the current landscape of clinical enthusiasm and regulatory caution, key challenges facing approval, and potential regulatory requirements. Panelists Dr. Owen Muir, Dr. Boris Heifets, and Andrew Penn share their insights on functional unblinding in clinical trials, safety monitoring, and provider qualifications. The episode concludes with a look at the future of psychedelic medicine and the potential impact of the FDA's decision on mental health treatment.
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