article thumbnail

Psychedelic Breakthroughs: Key Considerations for Clinical Trials

Healthcare Law Insights blog

Informed Consent: Ongoing and Essential Respecting patient rights is central to any clinical trial. Essential to this is ensuring ongoing informed consent from participants. The principle of informed consent extends to the practice of therapeutic touch, a component particularly relevant to psychedelic-mediated therapy.

article thumbnail

Analysis of U.S. Food and Drug Administration Draft Guidance on Clinical Trials with Psychedelic Drugs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. CGMP recommendations for investigational drugs intended for phase II and III trials are discussed in the May 2003 guidance “INDs for Phase 2 and 3 Studies; Chemistry, Manufacturing, and Controls Information”. All comments should be identified with the docket number FDA-2023-D-1987.

professionals

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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.

article thumbnail

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

GeriPal

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 we were able to work under a waiver of informed consent with making the case that we were promoting, which should be standard of care.

Document 156