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Validation of an Administrative Knee Osteoarthritis Severity Index in a Veterans Health Affairs Cohort [Big data]

Annals of Family Medicine

Objective: To validate the use of OASI among patients with knee OA to predict TKA in Veterans Health Affairs-Corporate Data Warehouse (VHA-CDW) administrative dataset. The first OA diagnosis in record must occur from 2009-2014 and index date is OA diagnosis date. Final sample size was 435,731. Outcome Measures: Time to TKA.

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Empowerment Self-Defense Arms ED Staff Against Rising Workplace Violence

Physician's Weekly

For physicians, nurses, medical assistants, and support staff, workplace violence (WPV) is now a daily hazard, inflicting physical injury, emotional trauma, and eroding the quality of patient care. Violence in hospital emergency departments (EDs) has reached crisis levels. The Warner Bros.

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Here We Go Again

Adventures of a Sick Doctor

I opened my diary (an actual physical book, not Outlook) and the silver ribbon is firmly stuck in the week of Wednesday 22nd May. Still though, he usually perks up when I come in, because he gets to show me my scans from November 2014 and compare them with now and we both applaud the wondrousness of the miracle that is my recovery.

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

FDA Law

In fact, stakeholders have repeatedly challenged FDA’s assertions of authority in Citizen Petitions, public comments, and other forums. Premarket Approval or De Novo pathways).

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Approaches for Quelling Stigma related to COVID-19

BMJ

quarantine-breakers”) or video clips of people shouting at or even physically assaulting Wuhanese or people who visited Wuhan after the outbreak. How to reduce the negative psychological impact MRSA isolation on patients. 2014 (28 August). National involvement is also needed to facilitate these efforts. doi:10.3389/fcomm.2020.00039

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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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

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).

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Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 2)

FDA Law

A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. FDA-2022-E-3124 ).

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