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Development of a Multidisciplinary Clinic for the Treatment of Obesity in a Canadian University Family Medicine Group (U-FMG) [Obesity, exercise and nutrition]

Annals of Family Medicine

Context In 2018, 63.1% Objective To implement and evaluate a novel multidisciplinary trajectory aimed at improving the treatment of obesity thus preventing multiple health-related complications. Follow-up frequency, ranging from weekly to monthly for up to 12 months, is tailored to individual needs.

DO 130
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Caring for Patients with Duchenne Muscular Dystrophy in the Emergency Department: A Problem-Based Approach

PEMBlog

The condition affects multiple organ systems—muscular, cardiac, and respiratory—leading to a myriad of clinical complications. Once patients become non-ambulatory, they often develop secondary complications like lymphedema, which further complicates their care. 2018 Oct;142(Suppl 2):S72-S81. 2018-0333I. Pediatrics.

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A prophylactic treatment for hemophilia that you should know about

PEMBlog

Emicizumab (Hemlibra) was approved in 2018 for routine bleeding prophylaxis in hemophilia A with or without inhibitors. Rather, it can change the bleeding phenotype from severe hemophilia to mild hemophilia – thus potentially reducing the risk of complications. How to know if a patient is on it? This is a black box warning.

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FDA Creates a New Advisory Committee for Genetic Metabolic Diseases – Could This Be an Opportunity to Support Rare Disease Product Development More Broadly?

FDA Law Blog

Janet Maynard, Director of this Office, highlighted in the press release that “[g]enetic metabolic diseases include very rare diseases that individually affect a limited number of patients. GeMDAC’s mandate is to advise the Agency on these complicated issues in this challenging area of medical product development.

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Rethinking Opioid Conversions: Mary Lynn McPherson and Drew Rosielle

GeriPal

I think part of it’s the math, but I think what really happened is, I think the story here is that in 2018, MD Anderson published this really landmark study by Dr. Reddy and her colleagues about going from IV Dilaudid to other to oral Dilaudid, oral hydromorphone, I should say, oral morphine and oral oxycodone. The old table, 1.5

IT 139
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Diabetes in Late Life: Nadine Carter, Tamryn Gray, Alex Lee

GeriPal

Our last podcast was with Laura Petrillo in 2018 – 5 years ago seems ancient history – though many of the points still apply today (e.g. And I can only imagine that’s even more complicated in the cancer patient population, where we’re asking them to do so many other things as well. Goldilocks zone).

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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

FDA Law Blog

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 These AI requests often address complicated scientific scenarios in which a submitter has already provided some information, but FDA is not completely satisfied. Average Number of Industry Days to MDUFA IV Decision 54.69