2023, Document, Information and Informed consent

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Analysis of U.S. Food and Drug Administration Draft Guidance on Clinical Trials with Psychedelic Drugs

Healthcare Law Insights blog

JUNE 30, 2023

On June 23, 2023 the U.S. Food and Drug Administration (FDA) published a draft guidance document with foundational considerations for researchers that are developing psychedelic drugs for the treatment of medical conditions. psilocybin and lysergic acid diethylamide (LSD)) as well as entactogens or empathogens (e.g.,

Document

Document Informed consent 2003 2010

Jumpstarting Goals of Care Convos: Erin Kross, Bob Lee, and Ruth Engelberg

GeriPal

JULY 13, 2023

They found a difference of 4% in documented goals of care discussions. Randy died February 26, 2023. And I think that his research was informed by his clinical practice, his clinical practice was informed by his research. And so that’s how we were able to proceed with the study under this waiver of consent.

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Document Palliative care 2018 Palliate

Home Care & Hospice Network

Analysis of U.S. Food and Drug Administration Draft Guidance on Clinical Trials with Psychedelic Drugs

Jumpstarting Goals of Care Convos: Erin Kross, Bob Lee, and Ruth Engelberg

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