The Food and Drug Administration (FDA) has released first-of-its-kind draft guidance on the “unique” considerations that researchers should take into account when studying psychedelics, which the agency says show “initial promise” as potential therapies.
Two days after bipartisan congressional lawmakers filed a bill to direct the issuance of such guidance, FDA published a 14-page draft document that appears to be responsive, providing scientists with a framework to carry out research that could lead to the development of psychedelic medicines.
A notice about the move is set to be published in the Federal Register on Monday. At that point, a 60-day public comment period will open for interested parties to submit feedback on how final guidance should be shaped.
This is the first FDA draft guidance that presents considerations to industry for designing clinical trials of psychedelic drugs.
— U.S. FDA (@US_FDA) June 23, 2023
“Psychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders. However, these are still investigational products,” Tiffany Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, said in a press release on Friday. “Sponsors evaluating the therapeutic potential of these drugs should consider
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