Psychedelic Drugs: Considerations for Clinical Investigations

Key changes

Provides recommendations on clinical trial design, including blinding, the role of psychotherapy, and safety monitoring requirements for drugs with potential psychoactive effects. It addresses the unique safety profile of psychedelics and the need for robust adverse event collection.

PV impact

Clinical safety and PV teams must ensure that safety monitoring protocols for trials involving psychedelics comply with these specific FDA recommendations, particularly regarding the detection and reporting of psychoactive side effects and abuse potential.

Exact policy details

Docket Number

FDA-2023-D-1987

Applies to: Applicable to clinical trials for psychedelic drugs.

Docket Number: FDA-2023-D-1987 · p. 1 · High · Source

Guidance Published Date

July 2026

Applies to: The guidance is effective from this date.

Published at: July 2026 · p. 1 · High · Source

Nonclinical Program Requirement

Follow ICH guidance M3(R2)

Applies to: Nonclinical studies for psychedelic drugs should align with ICH guidelines.

The nonclinical program for psychedelic drugs should follow recommendations outlined in the ICH guidance for industry M3(R2). · p. 7 · High · Source

IND Inclusion Requirements

Pharmacological and toxicological studies are required

Applies to: An IND must include adequate safety information before initiating human trials.

An IND must include adequate information about pharmacological and toxicological studies. · p. 7 · High · Source

Abuse Potential Assessment Requirement

Abuse potential evaluation is mandatory

Applies to: All new drug applications must include an assessment of abuse potential.

The assessment of the abuse potential of a drug product under development is generally conducted as a component of its safety evaluation. · p. 10 · High · Source

Workflow rule impacts

Extracted documents

• Guidance for Industryhtmlhtml · high · 1 page
• Download the Final Guidance Documentpdfpdf_text · high · 16 pages
• Search for FDA Guidance Documentshtmlhtml · high · 1 page
• Advisory Committee Guidance Documentshtmlhtml · high · 1 page