The FDA finalized clinical guidance for psychedelic drug developers and scheduled a public hearing on future therapeutic use, signaling that regulators are moving from research-stage oversight toward a clearer pathway for clinical development. The agency’s action adds momentum to a class of therapies that is approaching broader review readiness. In parallel, the FDA has proposed changes aimed at simplifying drug establishment registration for factories that produce products for the U.S. market, part of an effort to reduce friction in manufacturing oversight and strengthen the drug supply chain. Separately, outside of agency mechanics, CSPI warned that the FDA’s “one pivotal trial” policy could increase the risk of approving drugs with inadequate evidence of efficacy—citing an assessment of approvals from 2018–2021 that previously required a second trial to confirm benefit.