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Labeling updates and warnings through April 2009 for insulin pens and cartridges
Labeling updates and warnings through April 2009 for insulin pens and cartridges
FDA has issued an alert to remind healthcare professionals that insulin pens and cartridges are not to be shared among patients. Sharing pens or cartridges may lead to transmission of blood-borne pathogens such as hepatitis viruses and HIV. FDA has received information that insulin pens may have been shared among >2,000 patients in 1 hospital from 2007 to 2009 and among fewer patients in ≥1 other hospital. The disposable needles in the insulin pens were reportedly changed for each patient, but there is still a risk of blood contamination of the pen reservoir or cartridge. Some of these patients have tested positive for hepatitis C, but a link to the shared insulin pens or cartridges has not been established.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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Diabetes Management & Telehealth with Leslie Kolb
June 11th 2020Association of Diabetes Care and Education Specialists, chief science and practice officer, Leslie Kolb chats with MHE Associate Editor Briana Contreras in MHE's newest podcast Tuning into the C-Suite about diabetes management and how it's affected by the use of telehealth, especially during the current and trying times of the COVID-19 pandemic.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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