Psychedelic Medicine Sector

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>>> FDA issues draft guidance for research into psychedelics


UPI News

June 23, 2023

by Patrick Hilsman


https://www.msn.com/en-us/health/medical/fda-issues-draft-guidance-for-research-into-psychedelics/ar-AA1cWXg4


June 23 (UPI) -- The Food and Drug Administration issued guidelines Friday for scientific research with psychedelics. Among the requirements, researchers will have to submit critical information on what substances are being used.

"Sponsors must provide chemistry, manufacturing and controls information to ensure proper identification, quality, purity and strength of the investigational drug substance and drug product," the FDA said.

The agency added: "The evidentiary standard for establishing effectiveness of psychedelic drugs is the same as for all other drugs."

The FDA is seeking comments from industry, investigators and the public by Aug. 23, after which the agency will begin work on a final version of the guidance.

The document describes primary considerations in the drug development process, which includes the manner in which trials are conducted, data collection, safety of the subjects and and new drug application requirements.

"For example,' the FDA noted. "psychedelic drugs may produce psychoactive effects such as mood and cognitive changes, as well as hallucinations.

"As a result, there is the potential for abuse of these drugs, which is a drug safety issue that requires careful consideration and putting sufficient safety measures in place for preventing misuse throughout clinical development.

The stimulus behind the guidelines was "growing interest in the therapeutic potential of psychedelic drugs in recent years," the FDA said in a statement.

"They are being evaluated for use in the potential treatment of conditions such as depression, post-traumatic stress disorder, substance use disorders and other conditions."

In its draft guidance, the agency said, "Because this is an emerging area of drug development, there is limited experience as to the configuration of programs that may support approval of a psychedelic drug,

"Designing clinical studies to evaluate the safety and effectiveness of those compounds presents a number of unique challenges."

The director of the FDA's Division of Psychiatry, Tiffany Farchione, said, "Psychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders.

"However, these are still investigational products. Sponsors evaluating the therapeutic potential of these drugs should consider their unique characteristics when designing clinical studies."

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