Description
The U.S. Food and Drug Administration (FDA or Agency) is issuing this guidance to provide general considerations to sponsors developing psychedelic drugs for treatment of medical conditions (e.g., psychiatric disorders, substance use disorders). For the purposes of this guidance, the term psychedelic is used as shorthand to include classic psychedelics, typically understood to be 5-HT2 agonists such as psilocybin and lysergic acid diethylamide (LSD), as well as entactogens or empathogens such as methylenedioxymethamphetamine (MDMA).
Scope & Applicability
Product Classes
1General considerations for sponsors developing psychedelic drugs for medical conditions; Considerations for clinical investigations
Stakeholders
3Healthcare provider with graduate-level training
Entities studying the therapeutic potential of psychedelic drugs
CSS performs the scientific evaluation of the abuse potential
Regulatory Context
Attributes
2Key tests for vaccine purity should be validated
requirement for sameness between generic and RLD
Identified Hazards
Hazards
1Potential effect on public health risks
Related CFR Sections (6)
- 21CFR312.23§ 312.23 IND content and format.
(a) A sponsor who intends to conduct a clinical investigation subject to this part shall submit an “Investigational New Drug Application” (IND) including, in the following order:Read full regulation →
- 21CFR312.21§ 312.21 Phases of an investigation.
An IND may be submitted for one or more phases of an investigation. The clinical investigation of a previously untested drug is generally divided into three phases. Although in general the phases are conducted sequentially, they may overlap. These three phases of an investigation are a follows:Read full regulation →
- 21CFR1301.18§ 1301.18 Research protocols.
(a) A protocol to conduct research with controlled substances listed in Schedule I shall be in the following form and contain the following information where applicable:Read full regulation →
- 21CFR312.32§ 312.32 IND safety reporting.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 21CFR314.126§ 314.126 Adequate and well-controlled studies.
(a) The purpose of conducting clinical investigations of a drug is to distinguish the effect of a drug from other influences, such as spontaneous change in the course of the disease, placebo effect, or biased observation. The characteristics described in paragraph (b) of this section have been develRead full regulation →
- 21CFR312.42§ 312.42 Clinical holds and requests for modification.
(a) General. A clinical hold is an order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. The clinical hold order may apply to one or more of the investigations covered by an IND. When a proposed study is placed on clinical hold, subjectRead full regulation →
Related Warning Letters (10)
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
SV Labs Corporation
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Guangdong Renhe Guozhuang Biotechnology Co., Ltd.
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Medinatura New Mexico, Inc.
- 2025-12-16
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Sklar Personal Care Inc.
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CGMP/Deviations/Biologics License Application (BLA)
Microvascular Tissue, Inc.
- 2025-12-11
CGMP/Finished Pharmaceuticals/Adulterated
Catalent Indiana, LLC
- 2025-12-09
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DeVere Manufacturing Inc.
- 2025-12-09
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- 2025-12-09
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Seaway Pharma Inc.
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PQ Pharmacy, LLC
See Also (8)
- Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for Industry (Status: Final)
- Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products: Guidance for Industry (Status: Final)
- Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format -- Investigational New Drug Applications (INDs) (PDF) (Status: Final)
- Current Good Manufacturing Practice for Phase 1 Investigational Drugs: Guidance for Industry (Status: Final)
- Potency Tests for Cellular and Gene Therapy Products: Final Guidance for Industry: (Status: Final)
- Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators (Status: Draft)
- Analytical Procedures and Methods Validation for Drugs and Biologics (Status: Final)
- Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information: Guidance for Industry (Status: Final)