Technology firm Leidos, which provides support to every federal agency focused on health, says it’s bullish on artificial intelligence. What’s next: The public has 60 days to submit comments to the FDA.ĪI is seen by some as a burnout-fighting tool.
“Should a psychedelic drug that is a Schedule I controlled substance receive FDA approval as a drug product, the abuse potential assessment would assist in determining an appropriate rescheduling action under the Controlled Substances Act,” the guidance says. Researchers should collect data about the drugs’ abuse potential during development, according to the guidance. Many psychedelics are Schedule I controlled substances that the Drug Enforcement Administration also regulates to prevent misuse. Safety warning: The guidance also highlights the potential risks of psychedelic treatments, given that the drugs can produce mood and cognitive changes and hallucinations. “The goal is to help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications,” Tiffany Farchione, director of the division of psychiatry at the FDA’s Center for Drug Evaluation and Research, said in a statement.
The breakdown: The bulk of the new guidance details basic considerations for researchers during the drug development process, including: On Friday, the agency released draft guidance for researchers designing clinical trials for the drugs. Growing interest in psychedelics’ potential as treatments for conditions like depression and post-traumatic stress and substance-use disorders has prompted the Food and Drug Administration to set some guardrails. Psychedelics therapy is the new frontier in treating depression.
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