Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways
Agency IQ
AUGUST 16, 2024
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. While the ability to describe and specify aspects of the therapy is limited, the agency can specify the number and licensure of therapists who would participate in the MDMA treatment.
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