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FDA Psychedelics Hearing Focuses On Boosting Therapeutic Innovations While Adhering To Scientific Standards

The Food and Drug Administration (FDA) hosted a hearing on psychedelic therapy on Monday, with the agency and other federal partners that participated taking testimony from dozens of advocates, researchers and industry participants.

Eighty invited witnesses were given two minutes each to briefly summarize their stances and flag issues for federal officials.

Prior to the start of testimony, Marta Sokolowska, deputy director for substance use and behavioral health at FDA’s Center for Drug Evaluation and Research, said that the hearing is “part of a whole of government effort to better understand the opportunities, challenges and public health considerations associated with this evolving area of psychedelic drug treatment.”

“There have been growing interest and active research on the therapeutic potential of psychedelic drugs, in particular for treatment of serious mental health conditions,” she said, noting that as of this weekend, more than 1,800 people had registered for the hearing.

Sokolowska said that FDA has taken “a number of steps to advance psychedelic drug development” in recent years, including publishing guidance for researchers, partnering with other agencies and taking regulatory actions.

Its most recent actions, she said, are intended to support an executive order that President Donald Trump signed earlier this year

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