{"description":"Documents matching 'psychedelic' and published on or after 04/18/2026","count":6,"total_pages":1,"results":[{"title":"Psychedelic Drugs: Considerations for Clinical Investigations; Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled \"Psychedelic Drugs: Considerations for Clinical Investigations.\" Because interest in the therapeutic potential of psychedelic drugs has been increasing and designing clinical trials to evaluate these compounds presents unique challenges, FDA developed the draft guidance to present foundational aspects for sponsors to consider. This final guidance provides general considerations for sponsors developing psychedelic drugs for the treatment of medical conditions (e.g., psychiatric disorders, substance use disorders) and discusses recommendations for clinical investigations psychedelic drugs. This guidance finalizes the draft guidance of the same title issued on June 26, 2023.","document_number":"2026-14158","html_url":"https://www.federalregister.gov/documents/2026/07/14/2026-14158/psychedelic-drugs-considerations-for-clinical-investigations-guidance-for-industry-availability","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-14/pdf/2026-14158.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-14158.pdf?1783946717","publication_date":"2026-07-14","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"announcing the availability of a final guidance for industry titled “<span class=\"match\">Psychedelic</span> Drugs: Considerations for Clinical Investigations.” Because interest in the therapeutic potential of <span class=\"match\">psychedelic</span> drugs has been increasing and designing clinical trials to evaluate these compounds presents unique challenges, FDA developed the draft guidance to present foundational aspects for sponsors to consider. This final guidance provides general considerations for sponsors developing <span class=\"match\">psychedelic</span> drugs for the treatment of medical conditions (\n e.g., \n psychiatric"},{"title":"Considerations for Potential Future Therapeutic Use of Psychedelic Drugs; Public Hearing; Request for Comments","type":"Notice","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing a public hearing on the potential future therapeutic use of psychedelic drugs. In collaboration with federal partners, FDA is holding this public hearing to obtain feedback and perspectives on issues associated with the potential future therapeutic use of drug products containing a psychedelic drug substance in supervised and supportive settings.","document_number":"2026-14155","html_url":"https://www.federalregister.gov/documents/2026/07/14/2026-14155/considerations-for-potential-future-therapeutic-use-of-psychedelic-drugs-public-hearing-request-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-14/pdf/2026-14155.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-14155.pdf?1783946716","publication_date":"2026-07-14","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"approvals to help increase access to <span class=\"match\">psychedelic</span> drugs for serious mental illness, and which directs HHS and FDA to collaborate with other federal departments and agencies, as appropriate and consistent with applicable law, to increase clinical trial participation, data sharing, and real-world evidence generation regarding <span class=\"match\">psychedelic</span> drugs. \n Given this background, and as part of that coordinated federal effort, FDA and federal partners seek input on considerations for the potential future therapeutic use of <span class=\"match\">psychedelic</span> drugs in supervised and supportive"},{"title":"Request for Information, Training and Care Delivery Models for Safe Administration of Potential FDA-Approved Psychedelic Therapies in Ambulatory Clinical Settings","type":"Notice","abstract":"On April 18, 2026, President Trump issued Executive Order (E.O.) 14401, \"Accelerating Medical Treatments for Serious Mental Illness\", acknowledging that individuals suffering from serious mental illness may not always respond to existing therapies. This request for information (RFI) solicits stakeholder feedback on training and care delivery models that could be used to ensure safe and effective delivery of potential future Food and Drug Administration (FDA)- approved psychedelic drugs, including drugs administered in ambulatory clinic settings, such as health centers and rural health clinics.","document_number":"2026-14146","html_url":"https://www.federalregister.gov/documents/2026/07/14/2026-14146/request-for-information-training-and-care-delivery-models-for-safe-administration-of-potential","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-14/pdf/2026-14146.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-14146.pdf?1783946715","publication_date":"2026-07-14","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Health Resources & Services Administration"}],"excerpts":"means of screening and identifying patients for these therapies, and counseling patients on what to expect during <span class=\"match\">psychedelic</span> administration? How do multiple providers (\n e.g., \n primary care and behavioral health providers) communicate plans for <span class=\"match\">psychedelic</span> therapies and/or collaborate to provide <span class=\"match\">psychedelic</span> therapies?\n \n \n • \n In-clinic day of drug administration: \n What training should be \n \n required of providers administering <span class=\"match\">psychedelic</span> therapies in an ambulatory clinic setting? What competencies do providers need to achieve to serve patients in"},{"title":"Design and Safety Considerations for Clinical Trials Involving Ibogaine Drug Products; Request for Information","type":"Notice","abstract":"The Food and Drug Administration (FDA or the Agency) is describing the approaches it is considering for the design of early- phase clinical trials of ibogaine drug products and is opening a public docket to receive comments. The Department of Health and Human Services (HHS) is funding clinical development of ibogaine, and the first federally supported trials are expected to study ibogaine in adults with opioid use disorder (OUD) and adults with post-traumatic stress disorder (PTSD). FDA is building on the guidance for industry entitled \"Psychedelic Drugs: Considerations for Clinical Investigations\" by seeking comments, data, and information from the public on protocol elements relevant to ibogaine development--including dose selection and escalation, care setting, safety monitoring, eligibility criteria, stopping rules, and safety oversight, in part, because the Federal Government is funding work in this area. FDA will consider all information provided in response to this Request for Information (RFI) to inform whether and how these specific elements should be considered in its review of Investigational New Drug Applications (INDs) involving ibogaine.","document_number":"2026-20427","html_url":"https://www.federalregister.gov/documents/2026/10/06/2026-20427/design-and-safety-considerations-for-clinical-trials-involving-ibogaine-drug-products-request-for","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-10-06/pdf/2026-20427.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-20427.pdf?1791204314","publication_date":"2026-10-06","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"to help increase access to <span class=\"match\">psychedelic</span> drugs for serious mental illness, and it specifically notes that ibogaine compounds show potential in clinical studies to address serious mental illnesses for patients whose conditions persist after completing standard therapy. \n On July 14, 2026, FDA issued the final guidance for industry entitled “<span class=\"match\">Psychedelic</span> Drugs: Considerations for Clinical Investigations” (<span class=\"match\">Psychedelics</span> Guidance) (91 FR 43101). The guidance provides general considerations for sponsors developing <span class=\"match\">psychedelic</span> drugs for the treatment of certain"},{"title":"Accelerating Medical Treatments for Serious Mental Illness","type":"Presidential Document","abstract":null,"document_number":"2026-07907","html_url":"https://www.federalregister.gov/documents/2026/04/22/2026-07907/accelerating-medical-treatments-for-serious-mental-illness","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-22/pdf/2026-07907.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07907.pdf?1776784506","publication_date":"2026-04-22","agencies":[{"raw_name":"EXECUTIVE OFFICE OF THE PRESIDENT","name":"Executive Office of the President","id":538,"url":"https://www.federalregister.gov/agencies/executive-office-of-the-president","json_url":"https://www.federalregister.gov/api/v1/agencies/538","parent_id":null,"slug":"executive-office-of-the-president"}],"excerpts":"Innovative methods are needed to find long-term solutions for these Americans beyond existing prescription medications. \n <span class=\"match\">Psychedelic</span> drugs, including ibogaine compounds, show potential in clinical studies to address serious mental illnesses for patients whose conditions persist after completing standard therapy. Indeed, the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to specific <span class=\"match\">psychedelic</span> drugs, and there are numerous products currently in the clinical trial pipeline for review of safety and efficacy. It is"},{"title":"Notice Pursuant to the National Cooperative Research and Production Act of 1993-The Customer Experience Hub","type":"Notice","abstract":null,"document_number":"2026-19000","html_url":"https://www.federalregister.gov/documents/2026/09/16/2026-19000/notice-pursuant-to-the-national-cooperative-research-and-production-act-of-1993-the-customer","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-09-16/pdf/2026-19000.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-19000.pdf?1789476317","publication_date":"2026-09-16","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Antitrust Division","name":"Antitrust Division","id":23,"url":"https://www.federalregister.gov/agencies/antitrust-division","json_url":"https://www.federalregister.gov/api/v1/agencies/23","parent_id":268,"slug":"antitrust-division"}],"excerpts":"OF GREAT BRITAIN AND NORTHERN IRELAND; Inner Cosmos, Inc., Scotts Valley, CA; Invi Mindhealth, Inc., Parker, CO; IsoLinQ, Sugar Land, TX; Ist, LLC, Birmingham, AL; KBO Systems, Inc., Aurora, CO; Kintsugi Mindful Wellness, Inc., Berkeley, CA; Monash University Clinical <span class=\"match\">Psychedelic</span> Lab, Notting Hill, COMMONWEALTH OF AUSTRALIA; Motif Neurotech, Inc., Houston, TX; Neuro Animation, Inc., Columbia Fls, MT; Neuroblox, Inc., Cambridge, MA; NeuroSigma, Inc., Los Angeles, CA; North Carolina State University Foundation, Inc., Raleigh, NC; Novelna, Inc., Santa"}]}