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 Drug Framework: Policy and Clinical Implications (US, 2026)fda psychedelic framework, psychedelic drug regulation, clinical trial standards, policy implications, mdma and psilocybin trials, post-market surveillance, therapist training, state-federal policy, integration protocolshttps://mindmedicinelaw.com/briefing/optimi-health-s-phase-2-natural-psilocybin-trial-for-depression-canada-2026-20260910-40894The Psychedelic Journalen2026-09-11T15:04:59.220692+00:00Optimi Health's Phase 2 Natural Psilocybin Trial for Depression (Canada, 2026)optimi health, natural psilocybin, phase 2 trial, major depressive disorder, health canada, psychedelic clinical research, botanical drug regulation, plant-derived psychedelics, depression treatment trialshttps://mindmedicinelaw.com/briefing/fda-signals-regulatory-flexibility-for-psychedelic-assessment-20260910-40893The Psychedelic Journalen2026-09-11T15:04:34.777082+00:00FDA Signals Regulatory Flexibility for Psychedelic Assessmentfda, psychedelic 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/optimi-health-s-phase-2-psilocybin-trial-for-depression-canada-s-next-step-20260910-40566The Psychedelic Journalen2026-09-10T15:07:33.007936+00:00Optimi Health’s Phase 2 Psilocybin Trial for Depression: Canada’s Next Stepoptimi health, psilocybin trial, major depressive disorder, canada clinical trials, health canada, psychedelic-assisted therapy, phase 2 trial, regulatory pathways, mental health researchhttps://mindmedicinelaw.com/briefing/clinician-training-for-comp360-psilocybin-u-s-certification-program-emerges-20260910-40567The Psychedelic Journalen2026-09-10T15:07:01.222290+00:00Clinician Training for COMP360 Psilocybin: U.S. Certification Program Emergescomp360, psilocybin therapy, clinician training, fda approval, certificate program, psychedelic-assisted therapy, clinical infrastructure, treatment-resistant depression, standardization, regulatory policyhttps://mindmedicinelaw.com/briefing/epik-biosciences-ketamine-dxm-patent-filings-implications-for-psychedelic-ip-in--20260910-40568The Psychedelic Journalen2026-09-10T15:06:40.476078+00:00EPIK Biosciences' Ketamine/DXM Patent Filings: Implications for Psychedelic IP in Asia-Pacificepik biosciences, ketamine, dextromethorphan, provisional patent, psychedelic ip, combination medicines, asia-pacific, clinical trials, regulatory policy, patent thickethttps://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/anti-nmdar1-autoantibodies-and-psychiatric-outcomes-after-tbi-implications-for-g-20260908-40334The Psychedelic Journalen2026-09-10T15:08:57.166889+00:00Anti-NMDAR1 Autoantibodies and Psychiatric Outcomes After TBI: Implications for Glutamatergic Researchanti-nmdar1 autoantibodies, traumatic brain injury, depression, ptsd, glutamatergic modulation, biomarkers, psychiatric resilience, ketamine, clinical trials, neuroprotectionhttps://mindmedicinelaw.com/briefing/habenular-transcriptomics-illuminate-depression-subtypes-in-mice-20260908-40451The Psychedelic Journalen2026-09-10T15:08:36.013753+00:00Habenular Transcriptomics Illuminate Depression Subtypes in Micehabenula, single-cell rna sequencing, depression subtypes, mouse model, transcriptomics, precision psychiatry, psychedelic therapeutics, stress resilience, cell-type specificity, neurosciencehttps://mindmedicinelaw.com/briefing/gut-microbiota-inflammation-brain-axis-in-mdd-multi-omics-evidence-20260908-40504The Psychedelic Journalen2026-09-10T15:08:14.356849+00:00Gut Microbiota-Inflammation-Brain Axis in MDD: Multi-Omics Evidencegut microbiota, major depressive disorder, inflammation, multi-omics, brain connectivity, biomarkers, psychedelic research, clinical trials, neuroinflammationhttps://mindmedicinelaw.com/briefing/lsd-analogues-with-enhanced-safety-new-findings-from-ergolog-research-20260908-40491The Psychedelic Journalen2026-09-10T15:05:58.707186+00:00LSD Analogues With Enhanced Safety: New Findings From Ergolog Researchlsd analogues, ergologs, 5-ht2c agonists, psychedelic safety, drug development, clinical trials, receptor selectivity, u.s. fda, neuropsychiatric therapeutics, psychedelic regulationhttps://mindmedicinelaw.com/briefing/mystical-experiences-predict-ocd-improvement-after-psilocybin-20260908-40452The Psychedelic Journalen2026-09-10T15:05:21.321063+00:00Mystical Experiences Predict OCD Improvement After Psilocybinpsilocybin, ocd, mystical experience, clinical trial, psychedelic therapy, treatment-resistant, subjective experience, regulatory policy, integration, set and settinghttps://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 europehttps://mindmedicinelaw.com/briefing/ethical-challenges-in-mdma-assisted-therapy-trials-for-ptsd-20260901-40479The Psychedelic Journalen2026-09-10T15:07:53.053729+00:00Ethical Challenges in MDMA-Assisted Therapy Trials for PTSDmdma-assisted therapy, ptsd, clinical trials, ethics, informed consent, therapist-patient boundaries, regulatory approval, risk monitoring, therapist training