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Analysis of U.S. Food and Drug Administration Draft Guidance on Clinical Trials with Psychedelic Drugs

Healthcare Law Insights blog

On June 23, 2023 the U.S. Clinical FDA believes that the characteristics of psychedelic drugs present challenges in designing adequate and well-controlled (AWC) clinical studies. For one, the use of an inert placebo may present a challenge. All comments should be identified with the docket number FDA-2023-D-1987.

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Wash. Federal Judge Pokes Hole in New Wave of Vaccine Mandate Challenges

Healthcare Law Insights blog

In August 2023, a new crop of cases began appearing in federal courts, this time challenging public or private healthcare employer mandates under the Fourteenth Amendment’s due process and equal protection clauses, certain federal statutes, and numerous other purported “laws.” granted Wash. Governor Jay Inslee’s Motion to Dismiss.

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

GeriPal

Randy died February 26, 2023. And so Ruth highlighted one of the features of this pragmatic trial that was different than the outpatient trial was that we didn’t need to consent patients and families for participation in this study. And so that’s how we were able to proceed with the study under this waiver of consent.

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