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

Annals of Family Medicine

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

Community 130
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From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information

FDA Law Blog

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

Clinic 64
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A Final LDT Rule in April!? Will FDA be prepared?

FDA Law Blog

Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations. 14] Thus, while the Third-Party Review Program is not well‑utilized generally, it is not utilized at all by the in vitro diagnostic industry.

IT 69
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FDA’s Accelerated Approval of Biogen’s Aduhelm for Alzheimer’s: A Sign of Applying the Emergency Use Standard Beyond COVID?

FDA Law Blog

Subpart H) pathway in 2014, then issued it as final guidance in January 2019. It is noteworthy that this sentence that no clinical benefit has been established was deemed by FDA as unnecessary for Aduhelm to provide additional context beyond that the approval is based on reduction in amyloid beta plaques. What do we mean?

Clinic 98
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Private Equity Gobbling Up Hospices plus Hospice and Dementia: Melissa Aldridge, Krista Harrison, & Lauren Hunt

GeriPal

Eric: Whenever I hear about for-profit, non-for-profit, the differences between them, mostly everybody turns to, I think, your 2014 paper looking at the differences between for-profit and non-for-profit. Although I saw that hospice was providing a lot of really great quality care for these patients, I also saw a lot of problems.

Families 106
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Sweet! A Metabolic Disorders focused podcast episode

PEMBlog

She did her MD/PhD at Columbia University, where she investigated the diagnostic utility of exome sequencing for kidney disease. Therefore understanding these diseases, their presentations and their evaluation is critical for emergency medicine providers. It is not the job or the expectation of the EM provider. Pediatr Rev.

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RCT of PC in ED: Corita Grudzen, Fernanda Bellolio, & Tammie Quest

GeriPal

Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it. We weren’t randomizing providers or patients. Eric 26:01 Curtis’s, he had a 2014 JAMA article on simulation. This is not why I went into emergency medicine.