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FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances. As AgencyIQ discussed in-depth at the time , the committee grappled with data flaws and gaps within the context of positive trials and high unmet need.
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