SILVER SPRING, Md., Oct. 5 -- The U.S. Department of Health & Human Services' Food & Drug Administration issued the following press release:
The U.S. Food and Drug Administration today announced a request for information (RFI) describing approaches the agency is considering for the design of early-phase clinical trials of ibogaine drug products and seeking public input on those approaches. The RFI seeks comments, data, and information on specific protocol elements relevant to ibogaine drug development, including dose selection and escalation, care setting, safety monitoring, eligibility criteria, stopping rules and safety oversight. This RFI marks the latest FDA action to advance President Trump's April 2026 executive order on Accelerating...