FDA will issue formal guidance requiring mandatory cardiac monitoring protocols for ibogaine INDs before end of 2026

The FDA (the US drug regulator) will publish formal written guidance saying that any scientist testing ibogaine must monitor patients' hearts for dangerous rhythm problems. This matters because ibogaine can affect heart electrical activity, and the FDA has the data to back up this requirement—it just needs to publish the rule.

QT prolongation and arrhythmia data from current scoping reviews give FDA's Division of Psychiatry Products direct, documented justification. Guidance documents bypass full rulemaking and can move within months of a safety signal being formalized. The two-tier effect (hospital vs. outpatient) is a predictable structural consequence, not a policy goal, making this falsifiable: either the guidance exists with cardiac monitoring language by 2026-12-31 or it does not.