WASHINGTON, Oct. 6 -- Food and Drug Administration has issued a notice called: Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information.
The notice was published in the Federal Register on Oct. 6 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA or the Agency) is describing the approaches it is considering for the design of early-phase clinical trials of ibogaine drug products and is opening a public docket to receive comments. The Department of Health and Human Services (HHS) is funding clinical development of ibogaine, and the first federally supported trials are expected to study ibogaine in adu...