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Key Facts GPs Should Know About GLP-1 Analogs

Family Medicine Initiative

mg or placebo in 2019. 15 Also, a systematic review (2019) of 50,452 diabetes patients did not show a statistically significant increase of the overall cancer risk (OR 1.04; 95% CI: 0.94 4 Chronic Kidney Disease The FLOW trial randomized 3,534 patients with chronic kidney disease and type 2 diabetes and started treating them with s.c.

Diabetes 130
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Overtreatment of prostate cancer in the active surveillance era

Common Sense Family Doctor

in 2019, with 78% receiving radiation therapy and 22% undergoing surgery. times more likely to develop urinary or sexual complications, 2.78 times more likely to develop urinary or sexual complications, 2.78 Watchful waiting refers to clinical observation only. A recent analysis of the U.S. in 2000 to 59.8%

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The Most Engaging Decision You’ll Read All Year – Five Stars

FDA Law Blog

FDA published a June 2019 guidance , which stated that manufacturers would not need to perform long-term studies or submit long-term data in PMTAs. At an October 2019 Meeting , FDA explained the application process and provided assurances that decisions would be made on each specific product in a submission—not the submission in its entirety.

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The Mycoplasma Comeback: Why This Atypical Pneumonia is Back – A PEMCurrents Podcast

PEMBlog

Learning Objectives Describe the clinical presentation, epidemiology, and complications of Mycoplasma pneumoniae infections in pediatric patients, including its atypical manifestations. Clin Infect Dis 2019; 68:13. Plus, well discuss whether M. pneumoniae even needs to be treated in the first place! UpToDate , 1 Nov. Epub 2024 Aug 3.

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FDA Announces It Will Now Regulate Devices as Devices

FDA Law Blog

As you may remember, Genus sued FDA back in 2019, alleging that FDA’s classification of, and putative regulation of, its barium sulfate products as drug products violated the FDCA because barium sulfate meets the statutory definition of medical device and therefore must be regulated as a device. Sponsors can then request a refund.

IT 52
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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 By Philip Won & Adrienne R. Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. But that is only the beginning.

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PEMPix 2024 Online Case #2: Flight of Passage

PEMBlog

It is believed that this sequestered portion of his lung placed him at an elevated risk for infections as this is a known complication of bronchopulmonary sequestration. 2019 Apr 1;48(4):e169-e174. References Palla J, Sockrider MM. Congenital Lung Malformations. Pediatr Ann. doi: 10.3928/19382359-20190326-02. PMID: 30986318.