Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways
Agency IQ
AUGUST 16, 2024
FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances. 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.
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