Tag Archive for: fda

FDA Sparks Debate Over the Role of Psychological Support In Psychedelic Clinical Trials

FDA Sparks Debate Over the Role of Psychological Support In Psychedelic Clinical Trials

While clinical research furthers its quest in proving psychedelics’ potential in treating a variety of psychiatric disorders, the debate now is the importance of psychological support in trials investigating psychedelic-assisted therapy.
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MDMA Successfully Treats PTSD in Another Phase 3 Trial Sponsored by MAPS

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"MDMA-assisted therapy for PTSD is on track to be considered for approval by the FDA in 2024," says MAPS founder and president Rick Doblin.
The Biggest Psychedelic News Stories of the Week – June 30

The Biggest Psychedelic News Stories of the Week – June 30

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In yet another eventful week in the psychedelics sphere, more clear signs depict psychedelics’ popularity and acceptance.
The FDA Issues Guidance on Designing Psychedelic Clinical Trials

The FDA Issues Guidance on Designing Psychedelic Clinical Trials

The Food and Drug Administration published a new draft guidance with the purpose to advise researchers on study design when investigating the potential of psychedelics.
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FDA Approves First Clinical Trial Using Naturally Sourced Psychedelics

This trial, using Filament Health's botanical drug candidates, is the first to assess the direct administration of psilocin.

Psychedelic Business Spotlight: October 29

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This week in psychedelic business news: MindMed's MDMA research pipeline to treat Autism Spectrum Disorder; Cybin EMBARKs; Awakn and MindCure partner to heal alcoholism.
FDA Authorizes Device to Quantify Psychedelics’ Effects on the BrainShutterstock.com

FDA Authorizes Cybin Device to Quantify Psychedelics’ Effects on the Brain

"This study of ketamine’s psychedelic effects while wearing headgear equipped with sensors to record brain activity could open up new frontiers of understanding," says Cybin's chief clinical officer.
FDA Green Lights Ketamine for Treatment of ALS

FDA Green Lights Ketamine for Treatment of ALS

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"This designation not only expedites our regulatory, clinical, and product development plans but also validates our belief in the potential of ketamine," says PharmaTher CEO Fabio Chianelli.