https://mindmedicinelaw.com/briefing/psilocybin-earns-second-fda-breakthrough-for-chemo-neuropathy-20260911-41054The Psychedelic Journalen2026-09-11T22:05:35.423772+00:00Psilocybin Earns Second FDA Breakthrough for Chemo Neuropathypsilocybin, fda breakthrough therapy, chemotherapy-induced neuropathy, definium, clinical trials, psychedelic medicine, oncology, drug development, regulatory policyhttps://mindmedicinelaw.com/briefing/fda-public-hearing-on-psychedelic-therapies-policy-signals-for-u-s-stakeholders-20260911-41055The Psychedelic Journalen2026-09-11T22:05:14.521758+00:00FDA Public Hearing on Psychedelic Therapies: Policy Signals for U.S. Stakeholdersfda public hearing, psychedelic therapies, federal policy, clinical trials, mdma, psilocybin, drug scheduling, risk management, implementation barriers, regulatory guidancehttps://mindmedicinelaw.com/briefing/dhs-proposal-to-end-60-day-grace-period-implications-for-psychedelic-research-ta-20260911-40743The Psychedelic Journalen2026-09-11T15:05:52.448726+00:00DHS Proposal to End 60-Day Grace Period: Implications for Psychedelic Research Talent in the USdhs proposal, 60-day grace period, nonimmigrant visa, psychedelic research, immigration policy, clinical trials, workforce risk, us startups, international talenthttps://mindmedicinelaw.com/briefing/optimi-health-s-200-participant-psilocybin-depression-trial-canada-s-expanding-c-20260910-41057The Psychedelic Journalen2026-09-11T22:06:03.090766+00:00Optimi Health’s 200-Participant Psilocybin Depression Trial: Canada’s Expanding Clinical Landscapepsilocybin depression trial, optimi health, canada clinical trials, psychedelic research, health canada, private sector trials, regulatory policy, clinical trial risks, psychedelic therapy, major depressive disorderhttps://mindmedicinelaw.com/briefing/fda-s-psychedelic-drug-framework-policy-and-clinical-implications-us-2026-20260910-41056The Psychedelic Journalen2026-09-11T22:04:56.383749+00:00FDA’s Psychedelic 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regulation, clinical trial design, drug development, policy shift, mdma, psilocybin, regulatory flexibility, safety standards, psychiatric drug approvalhttps://mindmedicinelaw.com/briefing/phase-2-psilocybin-trial-for-major-depression-u-s-launch-2027-20260910-40731The Psychedelic Journalen2026-09-10T22:04:23.420512+00:00Phase 2 Psilocybin Trial for Major Depression: U.S. Launch 2027psilocybin, clinical trials, major depressive disorder, phase 2, FDA, psychedelic therapy, mental health, regulatory policy, adverse events, efficacyhttps://mindmedicinelaw.com/briefing/compass-pathways-taps-fluence-for-comp360-psilocybin-provider-training-20260910-40734The Psychedelic Journalen2026-09-10T22:04:10.637430+00:00Compass Pathways Taps Fluence for COMP360 Psilocybin Provider Trainingcompass pathways, fluence, comp360, psilocybin therapy, provider training, fda rems, treatment-resistant depression, psychedelic workforce, clinical adoption, regulatory approvalhttps://mindmedicinelaw.com/briefing/fda-signals-openness-to-innovative-psychedelic-drug-development-20260910-40732The Psychedelic Journalen2026-09-10T22:03:54.891472+00:00FDA Signals Openness to Innovative Psychedelic Drug Developmentfda psychedelic policy, psychedelic clinical trials, drug development innovation, regulatory guidance psychedelics, mdma approval process, psilocybin research, adaptive trial design, expanded access programs, psychedelic therapy riskshttps://mindmedicinelaw.com/briefing/subjective-effects-in-psychedelic-trials-policy-and-clinical-implications-20260909-41132The Psychedelic Journalen2026-09-12T15:03:45.282612+00:00Subjective Effects in Psychedelic Trials: Policy and Clinical Implicationspsychedelic therapy, subjective effects, clinical trial design, regulatory policy, non-hallucinogenic analogs, therapeutic mechanisms, FDA guidance, insurance reimbursement, psychedelic experience, neurosciencehttps://mindmedicinelaw.com/briefing/debate-over-non-hallucinogenic-psychedelics-in-clinical-practice-20260909-40779The Psychedelic Journalen2026-09-11T15:06:30.257884+00:00Debate Over Non-Hallucinogenic Psychedelics in Clinical Practicenon-hallucinogenic psychedelics, psychoplastogens, psychedelic therapy, subjective experience, clinical trial design, scalability in medicine, set and setting, ecodelics, policy implications, pharmaceuticalizationhttps://mindmedicinelaw.com/briefing/hierarchical-framework-for-nociplastic-pain-implications-for-psychedelic-trials-20260909-40828The Psychedelic Journalen2026-09-11T15:06:15.976269+00:00Hierarchical Framework for Nociplastic Pain: Implications for Psychedelic Trialsnociplastic pain, hierarchical framework, biomarker stratification, psychedelic clinical trials, pain mechanisms, central sensitization, neuroimmune modulation, patient selection, mechanistic endpointshttps://mindmedicinelaw.com/briefing/ketamine-dissociation-as-ethical-signal-rethinking-clinical-duties-20260909-40778The Psychedelic Journalen2026-09-11T15:05:14.365514+00:00Ketamine Dissociation as Ethical Signal: Rethinking Clinical Dutiesketamine ethics, dissociation in psychiatry, dual-trajectory model, clinical trial design, informed consent, risk assessment, beneficence and non-maleficence, regulatory guidance, psychedelic therapy, contextual safeguardshttps://mindmedicinelaw.com/briefing/ukraine-considers-us-inspired-drug-policy-reforms-in-2026-20260907-40821The Psychedelic Journalen2026-09-11T15:06:46.948030+00:00Ukraine Considers US-Inspired Drug Policy Reforms in 2026ukraine drug policy, addiction prevention, us drug models, forensic pharmaceutical, psychoactive substances, criminal law reform, public health, international cooperation, substance use treatment, psychedelic researchhttps://mindmedicinelaw.com/briefing/portugal-releases-national-clinical-guidelines-for-psychedelic-therapies-20260901-40809The Psychedelic Journalen2026-09-11T15:05:33.146167+00:00Portugal Releases National Clinical Guidelines for Psychedelic Therapiesportugal psychedelic guidelines, clinical use of psychedelics, multidisciplinary collaboration, european drug policy, informed consent psychedelics, psychedelic therapy regulation, ethics in psychedelic medicine, psilocybin mdma ketamine clinical, public health policy europe