Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways
Agency IQ
AUGUST 16, 2024
Many commenters took issue with the guidance’s statement that, “The contribution of the psychotherapy component to any efficacy observed with psychedelic treatment has not been characterized. In the clinical studies, this consisted of a four-month course of treatment with three doses of MDMA administered in supervised therapy sessions.
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