Lexology June 26, 2023
On Friday, the U.S. Food and Drug Administration (FDA) published the draft guidance “Psychedelic Drugs: Considerations for Clinical Investigations,” which outlines the foundational constructs for investigating the therapeutic potential of these compounds. Below we summarize these special considerations for clinical studies of psychedelic drugs, including CMC compliance, nonclinical research, assessment of the substance’s abuse potential, and other clinical research issues. FDA invites comments on its draft guidance through August 23.
Interest in the therapeutic potential of psychedelic drugs has a long history across the globe. More recently, pharmaceutical companies, researchers, and academics have been evaluating the transformative potential of psychedelics through the pharmaceutical development pathway. Importantly, the Food, Drug, and Cosmetic Act (FDCA) and the Controlled Substances Act (CSA) can...
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