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Food and Drug Administration, HHS.
Notice of availability.
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been increasing and designing clinical trials to evaluate these compounds presents unique challenges, FDA developed the draft guidance to present foundational aspects for sponsors to consider.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 This guidance finalizes the draft guidance of the same title issued on June 26, 2023.
The announcement of the guidance is published in the Federal Register on July 14, 2026.
You may submit either electronic or written comments on Agency guidances at any time as follows:
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2023-D-1987 for “Psychedelic Drugs: Considerations for Clinical Investigations.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the final guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the final guidance document.
Kofi Ansah, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4334, Silver Spring, MD 20993-0002, 301-796-4158.
FDA is announcing the availability of a final guidance for industry titled “Psychedelic Drugs: Considerations for Clinical Investigations.” This final guidance outlines general considerations for drug development programs considering the therapeutic potential of psychedelic drugs for the treatment of medical conditions ( e.g., psychiatric disorders, substance use disorders). This final guidance applies to clinical trials on investigational products and addresses recommendations for study design, including considerations for data collection, data generation, and patient monitoring.
This guidance finalizes the draft guidance of the same title issued on June 26, 2023 (88 FR 41407). FDA considered docket comments received in response to the draft guidance as part of this revision. To enhance clarity, a few revisions were made in this revised version.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Psychedelic Drugs: Considerations for Clinical Investigations.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
FDA considered the applicability of Executive Order 14192, per OMB guidance in M-25-20, and finds this action to be neither regulatory nor deregulatory.
While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information relating to the protection of human subjects and institutional review boards in 21 CFR parts 50 and 56 have been approved under OMB control number 0910-0130. The collections of information in 21 CFR parts 210 and 211 relating to current good manufacturing practice requirements for drugs and biologics have been approved under OMB control number 0910-0139. The collections of information in 21 CFR part 312 relating to the investigational new drug applications pathway, which includes clinical trials and clinical trial design, the submission of chemistry, manufacturing and controls information, study protocols, and pharmacological and toxicology information under 21 CFR 312.23, and IND safety reports under 21 CFR 312.32, as well as related meetings between sponsors or applicants and FDA or other communication with appropriate FDA officials to obtain advice on the studies and other information necessary to support submissions, have been approved under OMB control number 0910-0014. The collections of information in 21 CFR part 314 relating to the submission of new drug applications, including the submission of data from a clinical study or studies under 21 CFR 314.50(d)(5) and risk evaluation and mitigation strategies, as well as related meetings between sponsors or applicants and FDA or other communication with appropriate FDA officials to obtain advice on the studies and other information necessary to support submissions, have been approved under OMB control number 0910-0001. In addition, the guidance recommends the use of questionnaires to assess clinical trial subjects' expectations about potential drug effects and at the end of treatment to improve data interpretability. The collection of information from “individuals under treatment or clinical examination in connection with research or prophylaxis to prevent a clinical disorder, [or] direct treatment of that disorder . . .” is not subject to review by OMB under 5 CFR 1320.3(h)(5).
Persons with access to the internet may obtain the guidance at https:// ( printed page 43103) ,www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-14158 Filed 7-13-26; 8:45 am]
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