FDA advisors say no to MDMA. What’s the impact? With Josh Hardman
Business Trip
Navigating MDMA's Approval Challenges
This chapter explores the intricacies of the FDA advisory committee's recent meeting on MDMA therapy for PTSD, highlighting critical concerns over data gaps and uncompleted liver toxicity tests. It contrasts personal testimonies supporting MDMA with strong opposition, leading to an overwhelming negative vote from the committee regarding its effectiveness. The discussion also emphasizes the complexity of regulatory evaluations in psychedelic research, taking into account ethical considerations, placebo effects, and societal stigma.
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