Remove 2023 Remove Events Remove Healthcare Remove Informed consent
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Analysis of U.S. Food and Drug Administration Draft Guidance on Clinical Trials with Psychedelic Drugs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. Clinical safety reporting should track all abuse-related adverse events (AEs), such as euphoria, hallucinations, stimulation, and emotional lability. All comments should be identified with the docket number FDA-2023-D-1987. Comments can be submitted to Regulations.gov.

article thumbnail

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

GeriPal

Randy died February 26, 2023. But I think that as Ruth was saying, while the prior Jumpstart was quite effective at both increasing frequency of and quality of both care conversations in the outpatient space, it was just too labor-intensive to think about implementing widely across a healthcare system. So within those variables.

Document 156