Articles and Blogs

In June 2023, the Food and Drug Administration (“FDA”) released Draft Guidance outlining its current view of the psychedelic research landscape. The Draft Guidance is aimed at researchers conducting clinical trials using psychedelic drugs. While the FDA does not define psychedelics, it indicated that the shorthand term “psychedelic” includes “classic psychedelics,” which are typically understood to... READ MORE

On May 2, 2023, in a move intended to accelerate the adoption of digital health technologies, the U.S. Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices. This draft guidance expands on previous FDA recommendations released in the midst of the... READ MORE

On June 6, 2023, the U.S. Food and Drug Administration (“FDA”) released draft guidance (“Draft Guidance”) updating Good Clinical Practices (“GCPs”) recommendations for interventional clinical trials involving human subjects. The Draft Guidance, which is aimed at enabling the incorporation of rapidly evolving technological and methodological innovations into clinical trials, is adapted from the International... READ MORE