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Churning out of insurance among patients with diabetes served in US Community Health Centers [Economic or policy analysis]

Annals of Family Medicine

Health insurance instability may be particularly challenging for patients with diabetes who need regular chronic care management to reduce the risk of diabetes complications. 46,844 patients were diagnosed with diabetes during study period. Study Design: Retrospective observational cohort study.

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Personalized medicine in a community health system: the Endeavor Health experience [Dissemination and implementation research]

Annals of Family Medicine

Context: Genomic and personalized medicine implementation efforts have largely centered on specialty care in tertiary health systems. In 2014, Endeavor Health (formerly NorthShore University HealthSystem) launched the Center for Personalized Medicine to catalyze the delivery of personalized medicine.

Community 130
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Is DCIS Cancer or Not?

AMMD

My first breast cancer scare was in 2014, when they discovered calcifications for the first time during a routine mammogram. This is why conventional physicians treat DCIS in patients with surgery, radiation, and sometimes chemotherapy. There are also the luminal epithelial cells closest to the center.

Diagnosis 130
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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law Blog

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

Clinic 64
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A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog

Indeed, recent jurisdictional developments suggest that a wide of array of stakeholders could have standing to challenge the Agency’s attempt to restrict access to commonly used LDTs, including individual laboratories, hospitals, physicians and healthcare providers who routinely use these tests, and patients who depend on them.

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Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments

FDA Law Blog

California Stem Cell Treatment Center, Inc., 2014); U.S. At the clinics, Defendants offer treatments that consist of extracting fat tissue from patients and, through a multi-step process, turning that tissue into a liquefied mixture of stem cells, other cells and cell debris known as Stromal Vascular Fraction (SVF). By Steven J.

Clinic 59
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Critics Suggest FDA Approving Aduhelm Will Erode the “Public Trust”: What About Patients’ Trust?

FDA Law Blog

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.