The FDA (the US drug regulator) will likely publish formal written guidance saying that anyone running clinical trials with ibogaine must have hospital-grade heart monitoring equipment. This matters because ibogaine can cause dangerous heart rhythm problems, and the FDA needs to document the safety rules before more people can test it.
Multiple published cardiac safety papers on ibogaine QT prolongation and ventricular arrhythmia constitute a formal pharmacovigilance safety signal. FDA has procedural obligations under 21 CFR to respond to documented safety signals affecting IND expansions. However, formal guidance documents (not just letters or advisory communications) require notice-and-comment periods that typically take 12-18 months. FDA may issue a safety communication or IND clinical hold letters rather than formal guidance within this window. Confidence reduced from 0.84 to reflect the distinction between informal regulatory action (likely) and formal published guidance (harder to achieve by Dec 2026).