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USFDA Guidance: Psychedelic Drugs-Considerations for Clinical Investigations

Recently last week Friday (23 June 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research released a draft guidance on "Psychedelic Drugs: Considerations for Clinical Investigations".

Psychedelic drugs, also referred to as hallucinogens, are a class of psychoactive substances that can profoundly alter perception, cognition, and consciousness. Hallucinations, enhanced sensory perception, altered thought patterns, and mood changes are among the subjective experiences produced by these substances.


In this guidance, the Food and Drug Administration (FDA) provides general considerations for sponsors developing psychedelics to treat medical conditions (such as psychiatric disorders and substance abuse disorders).


The guidance applies to clinical trials conducted under investigational new drug applications (INDs), including non-marketing clinical trials (e.g., research or academic studies). Its principles aim both to ensure the integrity of clinical trials and their reliability, as well as to support the ethical conduct of trials.


The potency and/or pharmacodynamics of psychedelic drugs should be adequately characterized in vitro and in vivo, as well as the following clinical pharmacology aspects should be considered by sponsors when developing psychedelic drugs.


Click this LINK to know more about what are the Considerations for Clinical Investigations for Psychedelic Drugs.


Also, CBER released another guidance "Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical" which addresses the urgent and immediate need for platelets for the treatment of active bleeding when conventional platelets are not available or are impractical.

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