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Key Takeaways from the FDA’s First Draft Guidance on Clinical Trials with Psychedelic Drugs

On June 26, 2023, the U.S. Food and Drug Administration (FDA) issued its first draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry (Guidance), which highlights...more

Psychedelic Drugs – Easing the Regulatory Hurdles for Development

Congress recently introduced a bill that could expand access to therapeutic psychedelics that are designated as Breakthrough Therapies. These products are potentially useful in treating addiction, depression, post-traumatic...more

Behavioral Health Trends for 2022

Over the last two years, behavioral health (BH) has been one of the biggest growth areas in the health care ecosystem, fueled by the Public Health Emergency (PHE) but in many ways an ignored, overlooked, understaffed, and...more

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