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FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances. However, the agency can describe a concomitant therapy in labeling for a product it has authority to regulate if it is essential for the therapeutic effect.
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