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Key Facts GPs Should Know About GLP-1 Analogs

Family Medicine Initiative

Yes, one year after stopping the medication, patients regain ½ – ⅔ of their previous weight loss: What are other clinical benefits? mg or placebo in 2019. mg or placebo in 2019. Tirzepatide (15 mg) showed slightly more noticeable effects than Semaglutide (2.4 Does the rebound effect really exist? over 40 months (ARR).

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Overtreatment of prostate cancer in the active surveillance era

Common Sense Family Doctor

Concerns about overdiagnosis of clinically insignificant prostate cancer through prostate specific antigen (PSA) screening motivated the 2018 American Academy of Family Physicians’ (AAFP) recommendation against routine screening for prostate cancer. Watchful waiting refers to clinical observation only. A recent analysis of the U.S.

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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. FDA said randomized clinical trials could be used, but so could observational studies with respect to cessation data. FDA also directed manufacturers to produce detailed marketing plans.

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

PEMBlog

Well cover its clinical presentation, epidemiology, diagnostic approach, and management, including why standard beta-lactam antibiotics wont work. Learning Objectives Describe the clinical presentation, epidemiology, and complications of Mycoplasma pneumoniae infections in pediatric patients, including its atypical manifestations.

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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. Most patients are afebrile by the third day of treatment and clinically improved within two weeks. 2019 Apr 1;48(4):e169-e174. References Palla J, Sockrider MM.

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FDA, in a RARE Act, Takes To Lobbying for a Change to the Orphan Drug Act

FDA Law Blog

But in May 2019, FDA approved a second amifampridine drug product, Jacobus Pharmaceutical Company, Inc.’s And with “must-pass” FDA legislation, comes a host of riders—pieces of FDA-related legislation not specific to UFA reauthorization, but that folks seek to get added to the UFA bill to address various issues and topics. Becerra.”

IT 40