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National variation in ASCVD risk between Pooled Cohort Equations and PREVENT [Cardiovascular disease]

Annals of Family Medicine

Study Design and Analysis This study utilized data from NHANES 2011-2019 to calculate two ASCVD risk scores for each eligible individual: one using the race-based PCE and the other using the race-agnostic PREVENT equation. Each individual was separated into clinically significant risk categories of <7.5%, 7.5-10%,

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Diabetes related complications among Ethiopian Jews-Outcomes of a 10 years cohort study in Israel [Population health and epidemiology]

Annals of Family Medicine

Multivariate analyses were conducted to evaluate adjusted hazard ratios for various demographic, clinical, and comorbid factors at the onset of the disease and after a 10-year follow-up period. Population: Jewish CHS members, aged 18+, diagnosed with T2D between 2000-2011, born in Israel or Ethiopia.

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Episode 148: Antiracism in Medicine Series Episode 4 – Dismantling Race-Based Medicine Part 2: Clinical Perspectives

The Clinical Problem Solvers

Nwamaka Eneanya and Jennifer Tsai to discuss the limitations and harms of race-based medicine in clinical practice. Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality.

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Using technology to reclaim our time

Today's Hospitalist

Since the mid-1990s, our capacity for innovation has never stopped as hospitalists navigate a complex landscape of acute illnesses, interprofessional collaborations and the imperative to provide efficient, high-quality care. Yet this expansion has come with a significant administrative burden, particularly that of clinical documentation.

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No Sleep ‘Til District Court: Jazz Sues FDA Over Sodium Oxybate Clinical Superiority Determination

FDA Law

This time, rather than use codes and patent certifications, the fight is over orphan drug exclusivity (“ODE”), with Jazz challenging FDA’s clinical superiority decision concerning sodium oxybate in the treatment of narcolepsy. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE. .

Clinic 52
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OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. The next town hall will focus on the clinical development of gene therapy products for rare diseases in February 2023.

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FDA Flexes its New FDORA Muscles in Withdrawing an Accelerated Approval

FDA Law

This is the third withdrawal of an accelerated approval FDA has performed, following Avastin in 2011 and Makena in 2023. Prior to FDORA’s enactment, the statute did not provide details on the withdrawal procedures other than offering an opportunity for an informal hearing.

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