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Position Statement on Measurement Based Care

Integrated Care News by CFHA

Rather, it is an evidence-based, collaborative process that mirrors the well-established framework of using physical symptom monitoring (e.g., vital signs, bloodwork laboratory findings, and other physical test data) as a means of guiding care over time. MBC is much more than simply administering behavioral health measures. 3, 5, 6) b.

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Risking It All For a New Business Model at Family Physicians of St. Joe

Family Physicians of St. Joseph

Larger companies now dominate the healthcare landscape, yet through innovation and a dedication to exceptional patient care, Family Physicians of St. They have remained independent and committed to caring for patients as a small practice, all the while introducing new ideas and setting new standards in Michigan’s Great Southwest.

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Q&A: Cannabis Use Tied to Reduced Working Memory

Physician's Weekly

Gowin and his colleagues analyzed data from 1,003 adults between 22 and 36 years of age who had functional magnetic resonance imaging (fMRI), urine toxicology, and cannabis use results collected at one academic site between 2012 and 2015 as part of the Human Connectome Project. The cohort (mean age, 28.7 PW: Did the results surprise you?

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PEMPix 2023 Online Case 1: A House Divided

PEMBlog

During that initial visit, her physical exam was notable for generalized abdominal tenderness. The patient completed the miralax cleanout followed by daily miralax, and started having soft, formed stools daily without any pain (Bristol type 4). 2012 Jan;5(1):67-70. She had a normal urinalysis and the abdominal x-rays seen here.

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Long Time Passing: Where Have All the De Novo Decision Summaries Gone?

FDA Law

In 2012, the FDCA was modified to allow the submission of a De Novo request without the need for a prior 510(k), and set a target review time by FDA of 120 days. This amendment allowed sponsors with low or moderate risk devices to proactively employ the De Novo process. These legislative changes helped.

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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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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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