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A Decade of Blogging!

Aspiring Minority Doctor

Okay, now I'll admit I've done a horrible job of keeping up with the blog lately especially given that this is only my fifth post of the year, but today is still super special for me. This blog has helped a lot with some of my successes. When I started this blog she had just turned 7, and now my baby is 17!

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

FDA Law

Peter Marks at James Valentine ’s FDA Rare Disease Town Hall session at the DIA Annual Meeting last month (see Pink Sheet coverage here ), this Hub is intended to serve as the Center of Excellence that we in the rare disease community have been calling for its establishment over the last several years.

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AI/ML-enabled Medical Devices Have Everyone’s Attention, Including FDA’s

FDA Law

Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Just a day earlier, FDA’s Center for Devices and Radiological Health (CDRH) released a list of the guidance documents the Center intends to publish in the upcoming 2024 fiscal year.

Medical 119
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4 Ways Temporary Medical Staff Maintain Patient Care

Barton Associates

In this blog, we’re going to outline four key ways temporary medical staff such as locum tenens providers can help healthcare facilities maintain continuity of high-quality patient care in the face of growing shortages. These professionals play a vital role in maintaining essential services and ensuring continuity of patient care.

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Hyberbaric Oxygen Therapy

Vascular Physician

What is Hyperbaric Oxygen Therapy and How it Helps Heal Wounds Hyperbaric oxygen (HBO) therapy involves treating patients with 100% oxygen (O2) at elevated atmospheric pressures in a specially designed chamber. Most patients lie on their backs or sit up just slightly.

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While the Orphan Battles Wages, Jazz Takes a Loss

FDA Law

Starting in 2022 with a patent certification requirement, both Jazz and Avadel have sued FDA over this drug, with Jazz most recently bringing suit challenging FDA’s decision that Avadel’s Lumryz (sodium oxybate) is clinically superior to Jazz’s Xywav (sodium oxybate) in 2023. The Court held that it does.

Clinic 111
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Critics Suggest FDA Approving Aduhelm Will Erode the “Public Trust”: What About Patients’ Trust?

FDA Law

Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. By James E. The practice of medicine was viewed as paternalistic.