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Any psychedelic approval carries restrictive Schedule II-style REMS and DEA controls.

Predicted 2026-06-25 · Resolves 2028-06-25 · regulation · USA
72%
ORACLE CONFIDENCE
⏳ Pending
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If a psychedelic drug does get FDA approval, it won't come with easy or open access. It will almost certainly require a special safety program — called a REMS (Risk Evaluation and Mitigation Strategy) — that limits who can prescribe it, where it can be given, and who can receive it. The DEA (the US agency that controls dangerous drugs) will also keep tight oversight. A patient death linked to an unsupervised session has made regulators more cautious, not less.

I won't sign off on loosened access. The Adelaide death shows what happens unsupervised. Tight controls are the only acceptable path to approval.

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