{"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been increasing and designing clinical trials to evaluate these compounds presents unique challenges, FDA developed the draft guidance to present foundational aspects for sponsors to consider.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 This guidance finalizes the draft guidance of the same title issued on June 26, 2023.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health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"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2026/07/14/2026-14158.html","cfr_references":[],"citation":"91 FR 43101","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on July 14, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-D-1987"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-07-14","updated_at":"2026-07-14T09:57:03.740-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-D-1987-0233","allow_late_comments":false,"id":"FDA-2023-D-1987-0233","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-D-1987","title":"Psychedelic Drugs: Considerations for Clinical Investigations; Draft Guidance for Industry; Availability"}],"document_number":"2026-14158","effective_on":null,"end_page":43103,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/07/14/2026-14158.xml","html_url":"https://www.federalregister.gov/documents/2026/07/14/2026-14158/psychedelic-drugs-considerations-for-clinical-investigations-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-14158?publication_date=2026-07-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-07-14/2026-14158/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1028,"last_updated":"2026-09-20 10:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-14/pdf/2026-14158.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-14158.pdf?1783946717","publication_date":"2026-07-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/07/14/2026-14158.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2023-D-1987","supporting_documents_count":0,"docket_id":"FDA-2023-D-1987","document_id":"FDA-2023-D-1987-0233","regulation_id_number":null,"title":"Psychedelic Drugs: Considerations for Clinical Investigations; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2026-07-15T16:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":43101,"subtype":null,"title":"Psychedelic Drugs: Considerations for Clinical Investigations; Guidance for Industry; Availability","toc_doc":"Psychedelic Drugs: Considerations for Clinical Investigations","toc_subject":"Guidance","topics":[],"type":"Notice","volume":91}