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Senate proposes new safety requirements for reusable devices

Senate proposes new safety requirements for reusable devices
February 9, 2016

The Senate Committee on Health, Education, Labor and Pensions today favorably reported a bill requiring manufacturers of reusable medical devices like duodenoscopes to submit cleaning instructions and validation data to the FDA before bringing these devices to market. The bill also seeks to clarify FDA guidance on when manufacturers should seek clearance from the agency before marketing their products.

Between 2012 and 2015, there were 25 incidents of drug-resistant infections related to closed-channel duodenoscopes, affecting 250 patients worldwide, according to a recent report.

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Legislators ask for national surveillance of neurological illnesses

February 9, 2016
The Senate health committee today recommended the establishment of a national surveillance system for neurological diseases.The objective of the “Advancing…
Breaking News

Senate proposes EHR fix for physicians, patients

February 9, 2016
The U.S. Senate Committee on Health, Education, Labor and Pensions unanimously recommended a measure today that would improve the use of electronic health records for…
In the Journals

Subclinical hypothyroidism in pregnancy increases adverse maternal, neonatal outcomes

February 9, 2016
Multiple adverse maternal and neonatal outcomes were found when subclinical hypothyroidism was present during pregnancy. According to the study researchers, the use of…
Breaking News

New bill supports young researchers

February 9, 2016
The Senate health committee recommended a bill today that would improve opportunities for new researchers in the United States. The “Next Generation Researchers…
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CME

Real-world Use of Anti-VEGF Therapy

This activity is supported by an educational grant from Genentech, Inc.

Anti-VEGF is well established as first-line therapy for the treatment of diabetic macular edema (DME) and age-related…
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VIDEO: Weight loss tips from the experts — Big changes lead to big results

November 23, 2015
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CMECNECPE

The Emerging Biosimilar Therapeutic Landscape: Scientific Foundations and Clinical Implications

This activity is supported by an educational grant from Boehringer-Ingelheim Pharmaceuticals, Inc. and Lilly USA, LLC.

Recent processes have been established to facilitate the production, validation, and utilization of biosimilars…
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