FDA response to the UMiami ibogaine IND will include an explicit cardiac-monitoring requirement (QT/telemetry) in any clinical-hold or clinical-comment communication before Nov 15, 2026.

The FDA (the US drug regulator) is widely expected to respond to the University of Miami's ibogaine study application by requiring strict heart monitoring for every participant — think continuous heart-rhythm tracking throughout the experience. This is because ibogaine is known to interfere with the heart's electrical system in ways that can cause sudden, life-threatening irregular heartbeats. The FDA won't approve any human dosing without guardrails around that risk.

Ibogaine's torsadogenic risk is well-documented; no reviewer signs off without cardiac guardrails. This is standard division practice, politics aside.