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

FDA Law

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

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RCT of Palliative Care for Heart Failure and Lung Disease: David Bekelman and Lyndsay DeGroot

GeriPal

He also found gaps, including very few studies of patients with lung disease, and little impact of trials on quality of life. ABIM MOC credit will be offered to subscribers in November, 2024. Your research is a lot in this patient population, right? The article we discuss today, also published in JAMA , addresses these two gaps.

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Substance Use Disorder in Aging and Serious Illness: A Podcast with Katie Fitzgerald Jones, Jessica Merlin, Devon Check

GeriPal

We start off the conversation by talking about whether patients with cancer and cancer pain are really that different, and their paper that was just published on January 11 th in JAMA Oncology showing that substance use disorder is not uncommon in individuals with cancer. For any MOC questions, please email moc@ucsf.edu.

Illness 136
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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? He died in 2024.

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EMS Intervention to Reduce Falls: Carmen Quatman and Katie Quatman-Yates

GeriPal

The insight started when Carmen, an orthopedic surgeon-researcher, and Katie, a physical therapist- researcher participated in ride-alongs with EMS providers to patient’s homes. Going into patient’s homes was eye opening. ABIM MOC credit will be offered to subscribers in November, 2024.

Community 114
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Surrogate Decision Making: Bernie Lo and Laurie Dornbrand

GeriPal

The Cruzan ruling led to a flood of interest in Advance Directives, and eventually to the Patient Self Determination Act, which mandates provision of information about advanced directives to all hospitalized patients. Bernie Lo discloses being an Honorarium Recipient and consultant for Takeda starting on 01/23/2024.

Family 112
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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. Updated February 26, 2024. Inhalant misuse reported to Americas Poison Centers, 2001-2021. Patients that use these will repeatedly use it throughout the day. References Perry H, Burns MM. Ganetsky M (ed).