By Michael Nedelman, CNN A recipe for headache prevention 00:59 (CNN)The US Food and Drug Administration on Monday announced the approval of a drug called ubrogepant for the acute treatment of migraine, which could be a new option for people who can’t take or don’t respond to migraine medications currently on the market. The drug...
Tag: <span>FDA</span>
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FDA slams Dollar Tree for purchasing drugs from suppliers with checkered safety records
By ED SILVERMAN @Pharmalot A mid growing concerns over the pharmaceutical supply chain, regulators sternly warned the Dollar Tree (DLTR), which runs a vast network of stores serving mostly low-income communities, for selling over-the-counter medicines made by companies that failed to ensure the drugs were safely manufactured and tested. In a Nov. 6 warning letter,...
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FDA: biotin supplements could affect results of medical tests
Biotin supplements can interfere with the results of some critical lab tests, the U.S. Food and Drug Administration warned Tuesday. The FDA is particularly concerned about biotin interference causing a falsely low result for troponin. The agency said in a statement that it continues to receive reports of cases in which biotin interference caused falsely...
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When your teen wants a tattoo
by Len Canter “Mom, can I get a tattoo?” Tats, along with body piercings, have become mainstream. The U.S. Food and Drug Administration reports that 29% of the population has at least one tattoo. So this is a question you’re likely to face as a parent. You may not be in favor of it, but...
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Homeopathy: FDA issue new statement on risks
By Ana Sandoiu Fact checked by Jasmin Collier As the homeopathic industry grows, the Food and Drug Administration (FDA) issue a statement to present two major steps they are taking to protect the public from the potentially harmful effects of products labeled as “homeopathic.” According to some estimates, a third of adults and more than...
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Scientists find solution to Gulf War Illness in FDA-approved antiviral drugs
by University of South Carolina A recent study led by scientists at the University of South Carolina’s Arnold School of Public Health has shown that adjusting GI tract viruses by repurposing existing FDA-approved antiviral drugs offers a route for effective treatment for Gulf War Illness and its myriad of symptoms. Their findings were published in...
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FDA expands warning against use of blood pressure drug
Patients taking affected medication should contact their pharmacist or physician. Arutz Sheva Staff The US Food and Drug Adminsitration (FDA) and Torrent Pharmaceuticals Limited expanded for the fifth time a warning against using a common blood pressure medication. The medication, Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, is being recalled to the consumer level due to detection of trace amounts of...
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FDA and EMA are now probing carcinogen in Zantac and other heartburn meds
By ED SILVERMAN @PharmalotSEPTEMBER 13, 2019 Regulators in the U.S. and Europe are investigating why traces of a possible carcinogen were found in certain heartburn drugs, including Zantac, more than a year after the same impurity was found in some blood pressure pills, a revelation that has raised questions about the safety of the pharmaceutical...
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Regulatory issues and challenges for 3D-printed medical devices
by Lander Veulemans 3D printing, a type of additive manufacturing, has been on the rise in the medical world. The process of creating a three-dimensional item by constructing successive layers of raw material has already proven its purpose in orthopedic surgery and related fields in the last 10 years. However, a new technique often entails...
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Swallowable device to detect Barrett’s esophagus receives FDA 510(k) clearance
by Case Western Reserve University Investigators at Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center developed the test for early detection of Barrett’s esophagus that offers promise for preventing deaths from esophageal adenocarcinoma. The test involves a novel swallowable balloon device that samples the esophagus and a DNA assay that...