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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law

When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them.

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FDA’s Draft Guidance on Externally Controlled Trials Answers Some Questions, Leaves Others Unanswered

FDA Law

This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources. The goal is to select similar patients in the treatment and external control groups. The Draft Guidance also states that sponsors must include in their marketing applications relevant patient-level data for both arms.

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Should you have a coach? Greg Pawlson, Beth Griffiths, & Vicky Tang

GeriPal

Hot off the presses RCT in JAMA October 2023: Study that looks at 1000 female resident physicians at 26 sites that showed that coaching improved each outcome assessed (burnout, moral injury, imposter syndrome, self-compassion, and flourishing). AlexSmithMD 1. Beth, welcome to GeriPal. Beth: Thank you. Greg, welcome to GeriPal. Beth: Yeah.

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Caring for the Unrepresented: A Podcast with Joe Dixon, Timothy Farrell, Yael Zweig

GeriPal

These individuals may become unrepresented, meaning they lack the capacity to make a specific medical decision, do not have an advance directive for that decision, and do not have a surrogate to help. How should we care for unrepresented individuals in inpatient and outpatient settings? Is the patient in your descriptor?

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Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

GeriPal

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. Ali John 11:34 Yep.

Illness 107
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A Podcast on Inhalant Misuse: From Glue to Galaxy Gas

PEMBlog

Formulate effective strategies for identifying, managing, and preventing inhalant misuse in pediatric patients. Inhalant misuse reported to Americas Poison Centers, 2001-2021. Clin Toxicol (Phila) 2023; 61:453. Patients that use these will repeatedly use it throughout the day. References Perry H, Burns MM.

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PC for People Experiencing Homelessness: Naheed Dosani

GeriPal

link] PEACH Good Wishes Program A program that provides meaningful gifts for unhoused individuals who are terminally ill. So we did a podcast on aging and homelessness with Margot Kushel in 2023. We talk a lot about people being unhoused, which I think takes the blame away from the individual and kind of de.