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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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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

Yet this expansion has come with a significant administrative burden, particularly that of clinical documentation. But these early systems often struggled with complex medical terminology and the natural flow of conversation. This isn’t about replacing your clinical judgment. It’s about augmenting your capabilities.

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

FDA Law Blog

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.

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510(k) Modernization 2023

FDA Law Blog

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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Texas invests $50M in psychedelic drug research to treat addiction

Medical Xpress

The goal is to support clinical trials and bring in another $50 million in private investment to help ibogaine win approval from the U.S. Other states like Oregon and Colorado have already launched legal clinics using psilocybin, the compound found in mushrooms, The Times reported. Food and Drug Administration (FDA).

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Rewiring the body clock: Deep brain imaging reveals unexpected complexity in jet lag adjustment

Medical Xpress

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