Key Takeaways from the FDA’s First Draft Guidance on Clinical Trials with Psychedelic Drugs

 

On June 26, 2023, the U.S. Food and Drug Administration (FDA) issued its first draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry (Guidance), which highlights considerations for sponsors developing psychedelic drugs for treatment of medical conditions (e.g., psychiatric disorders, substance use disorders) and for clinical trials that will be conducted under an investigational 

​ On June 26, 2023, the U.S. Food and Drug Administration (FDA) issued its first draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry (Guidance), which highlights considerations for sponsors developing psychedelic drugs for treatment of medical conditions (e.g., psychiatric disorders, substance use disorders) and for clinical trials that will be conducted under an investigational […] 

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