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Assessment of Project ECHO(R) Opioid Use Disorder Sessions for Primary Care Teams [Education and training]

Annals of Family Medicine

Unfortunately, most individuals suffering from OUD do not have access to necessary care. A critical shortage of clinicians who specialize in treating patients with OUD exacerbates this issue. Study Design and Analysis: PC teams (clinical and non-clinical roles) attended 12 online monthly OUD sessions.

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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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Clinical Trials Join the Remote Work Revolution: FDA’s New Draft Guidance on Decentralized Clinical Trials

FDA Law

Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories.

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Well Isn’t that Special: An Assessment of the Special Control Associated with Simple Point of Care COVID-19 Antigen Tests

FDA Law

In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device. analytical, clinical and stability). The Special Controls are silent on what would constitute appropriate levels of evidence necessary to satisfy this criterion.

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At Long Last, FDA Unveils Plan for Rare Disease Innovation Hub

FDA Law

This individual will play a key role in overseeing the new integrated Hub model and helping to develop and implement its strategic agenda action plan. According to FDA, the new Hub will have special focus on products intended for smaller populations and also for diseases where the natural history is variable and not fully understood.

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Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

FDA Law

In addition, manufacturers should identify whether the modifications will apply to all devices in the field (referred to as global adaptations) or will be implemented based on a specific clinical site or individual patients” (referred to as local adaptations).

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Caring for Patients with Duchenne Muscular Dystrophy in the Emergency Department: A Problem-Based Approach

PEMBlog

Duchenne Muscular Dystrophy (DMD) is a complex and progressive disease requiring highly specialized care, especially in emergency situations. The condition affects multiple organ systems—muscular, cardiac, and respiratory—leading to a myriad of clinical complications. Updated 2023 Jul 10]. Pediatrics. doi: 10.1542/peds.2018-0333I.