# US psychedelic therapy regulatory and research developments > Live situation record from CLSTR: https://clstr.news/situations/us-psychedelic-therapy-regulatory-and-research-developments > Updated: 2026-09-16T17:29:00.000Z. Sources: 6. Developments: 2. The U.S. Food and Drug Administration (FDA) is working to develop a new framework to accelerate patient access to psychedelic medicines, such as psilocybin and DMT, to address the national mental health crisis. During a public hearing, participants emphasized that these substances should be treated as part of a broader therapeutic package involving clinical preparation and provider training rather than as isolated drugs. In parallel with regulatory developments, researchers from several universities have proposed the UMBRAA framework to address scientific challenges in psychedelic clinical trials. They noted that current trials struggle with masking, as participants can often identify if they received a high dose due to altered consciousness. To prevent participant expectation from skewing results, researchers suggest using multidrug active placebos and limiting disclosed study information to ensure the true efficacy of these compounds can be rigorously established. ## Timeline ### 2026-09-16: Researchers propose new masking framework for psychedelic clinical trials Researchers propose using multidrug active placebos and limited disclosure to improve masking in psychedelic clinical trials, where high-dose effects often allow participants to guess their treatment. 2 sources. https://clstr.news/cluster/researchers-propose-new-masking-framework-for-psychedelic-clinical-trials ### 2026-09-14: FDA develops new framework for psychedelic therapies The FDA is establishing a new framework to speed access to psychedelic therapies for mental health, following public hearings focused on patient safety and the importance of assisted therapy models. 4 sources. https://clstr.news/cluster/fda-develops-new-framework-for-psychedelic-therapies --- Cite as: US psychedelic therapy regulatory and research developments. CLSTR, https://clstr.news/situations/us-psychedelic-therapy-regulatory-and-research-developments