Press Release
☷FDA Roundup January 19 2024
Food and Drug Administration ( By Press Release office)
Jan 21,2024
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Hey everyone , we ' ve got some news from the U . S . Food and Drug Administration to share with you today . They ' ve issued marketing denial orders to a couple of companies for their e - cigarette products , so they can ' t sell them in the U . S . anymore . The FDA also wants to remind everyone about the importance of laboratory developed tests and how they help doctors make decisions about patient care . They ' ve also issued a safety communication about certain recalled ResMed masks that could cause injuries or death for people with certain medical devices . Oh , and they ' re advising restaurants and retailers not to serve or sell oysters from Baja California , Mexico that might be contaminated with norovirus . Lastly , the FDA ' s Center for Devices and Radiological Health has released their 2023 Annual Report , which shows how they ' ve been working hard to ensure everyone has access to safe and effective medical devices . So , the FDA just announced on Wednesday that Emergent Biosciences is gonna give Narcan nasal spray a longer shelf - life . It used to be 3 years , but now it ' s gonna be 4 years . This is part of the FDA ' s efforts to prevent overdose deaths . And on Tuesday , the FDA said no to Shenzhen IVPS Technology ' s e - cigarette products . They didn ' t approve 22 different items , like devices , pods , atomizers , and cartridges . These products were being sold without e - liquid , so the FDA said they can ' t be distributed or marketed in the US . Also on Tuesday , the FDA warned patients and healthcare providers about problems with the Equinoxe Shoulder System joint replacement devices . Some of these devices , made by Exactech between 2004 and August 2021 , were packaged in faulty bags . These bags didn ' t have a layer that protects the devices from oxygen , which can cause them to wear out faster or even break . People with these devices might need more surgery to fix the problem . The FDA actually put out a warning about a similar issue with other Exactech joint replacement devices back in March 2023 .
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