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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. Intervention: 12 monthly online OUD sessions held from April 2023 to March 2024.

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Have Job-Based Health Coverage at 65? You May Still Want To Sign Up for Medicare

Physician's Weekly

When Alyne Diamond fell off a horse in August 2023 and broke her back, her employer-based health plan through UnitedHealthcare covered her emergency care in Aspen, Colorado. The insurer not only stopped paying current claims but also moved to claw back tens of thousands of dollars it had paid to providers in the two years since she turned 65.

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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 Blog

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. The Special Controls are silent on what would constitute appropriate levels of evidence necessary to satisfy this criterion. analytical, clinical and stability).

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

FDA Law Blog

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

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Empowering Women Physicians 2023 Bora Bora Retreat Recap and Reflections

Aspiring Minority Doctor

It made me feel so special and loved. Food is extremely expensive in Bora Bora, so I am so grateful for the room credit that this retreat provided, because just getting a burger, salad, and dessert was over $100. Even cooler, the photographer took individual headshots of us that will be able to use for branding or however we like.

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Clinical Trials Join the Remote Work Revolution: FDA’s New Draft Guidance on Decentralized Clinical Trials

FDA Law Blog

In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories. With regard to clinical trial visits and activities, the draft guidance provides examples of the types of approaches that may be possible with a DCT.

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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 Blog

FDA recommends that PCCPs specify only a “limited number” of modifications but does not provide a limit on the number of modifications that can be included. If the proposed performance evaluation methods are different from the original methods used, the manufacturer should describe the differences and provide a justification for the changes.