Not admitted · Outside the five areas
Rules 1.1.0 · as of 14 Sep 2026
Owen Scott Muir · Said 24 Jun 2023 · owen-0560
Quote
Outside the five areas
“I expect open comments to be left on this requirement. I’m kidding a little bit, but not that much.”
The draft guidance requires the lead monitor to be independently licensed (MD, DO, PhD/PsyD psychologist, MSW, LCPC, LMFT or psychiatric NP), so shaman-trained practitioners would not qualify. The author expects the public to file comments on this requirement during the FDA open comment period.
Outside the five area definitions in areas.json: not a regulatory decision, trial outcome, company or market outcome, payer or policy decision, or practice adoption about drugs, devices or treatments in psychiatry, or about payment for and access to them. The registry applies the same test when it consolidates proposed events.