Not admitted · Not a forecast
Rules 1.1.0 · as of 14 Sep 2026
Owen Scott Muir · Said 24 Jun 2023 · owen-0558
Quote
Not a forecast
“The most critical issue, at least to my eye, from a scalability perspective, is that for the clinical trials, the FDA is—in draft guidance— leaning both having two monitors”
The author reads the FDA's June 2023 draft guidance on psychedelic drug development. He singles out the requirement of two monitors per treatment session (a lead monitor with an independent clinical license plus an assistant) as the main scalability problem for future psychedelic clinical trials.
Descriptive, retrospective, or a statement of preference; no future state asserted.