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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. More than 35,000 patients completed clinical genetic testing following GWA or BHA completion.

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

FDA Law Blog

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). The SIUU Guidance, which supersedes the 2014 Draft GRP Guidance, is not substantially different in that regard and contains similar information as to the types of disclosures previously recommended.

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

FDA Law Blog

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. 2, 2014), [link]. [12] Searches were done for all IVD panels: immunology, microbiology, clinical chemistry, pathology, toxicology, hematology, and molecular genetics. [15]

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. However, the FDA guidance goes on to say in some cases, additional context is needed by specifically inserting a sentence in the indications statement that: no clinical benefit has been established.

Clinic 98
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RCT of PC in ED: Corita Grudzen, Fernanda Bellolio, & Tammie Quest

GeriPal

Why this study was a success due to the sheer size (nearly 100,000 patients in about 30 EDs) of the study, and the fact that, as far as the investigators know, all study sites continue to employ the clinical decision support tool. And then we had clinical decision support. What is a clinical decision support? Long overdue.

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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. On clinical presentation. Now, first off, realize that most IEMs present with very nonspecific clinical features. So what are some of these suggestive clinical features? Pediatr Rev. Pediatrics.

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RCT of Default Inpatient PC Consults: Kate Courtright & Scott Halpern

GeriPal

But you could have clustering within clinics, within clinicians who care for a panel of patients, that sort of thing. Kate: No, it’s a tough answer in part because, as Scott mentioned, this was being implemented somewhere in the 2014/15 range after funding and building and that pilot year. laughter] Eric: Enough said. Eric: Yeah.