Posts Tagged 'FDA'

Diabetes Drug Invokana No Longer Carries Boxed Warning

FDA drops invokana black boxWhen the FDA made the decision to give Johnson & Johnson’s diabetes drug Invokana a black box warning in 2017, one would like to believe that the decision was not made lightly. The boxed warning is the strongest warning the agency can issue for a drug on the US healthcare market and indicates that the product can pose grave risks to the consumer if used. There is no ...

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FDA Provides Hand Sanitizer Lab Test

contaminated hand sanitizer list now has over 170 brands to avoidIn response to the growing number of hand sanitizer products found to contain either inadequate levels of the right ingredients or toxic levels of contaminants, the Food and Drug Administration will begin making a lab test available to ensure the quality of these products. The agency’s website alludes to the fact that such testing of hand sanitizer products will be mandatory in ...

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Medtronic Stapler Litigation Shows Ties to Secret FDA Database

Medtronic stapler lawsuits show ties to secret fda loophole databaseWhen news broke of an internal FDA database of medical device injuries so secret that few within the agency even knew of its existence, the discovery obviously led to the raising of a multitude of questions. Why was an agency tasked with keeping American families safe allowing the companies it was supposed to be regulating to hide reports of injuries caused by their devices? Why was ...

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Why Was the FDA Keeping a Secret Database of Medical Device Injuries?

secret FDA database of medical device errors exposedAccording to the mission statement published on its website, the FDA “is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.”

One has to wonder then how an agency charged with such an important task can justify the existence of ...

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Report: FDA Knew Talc Asbestos Was Problematic for Decades, Did Nothing Due to Industry Pressure

fda knew about talc asbestos for decades and did nothingWhile Johnson & Johnson was issuing denial after denial over the presence of mesothelioma-causing asbestos in its talc-based products, it was also attending meetings with federal regulators to discuss the presence of asbestos in its talc-based products. As recently as the latter months of 2018, officials from the FDA met at a D.C.-area hotel with talc industry executives for the purpose of figuring out how much asbestos ...

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Confusion, Frustration as Vaping-related Illness Numbers Continue to Rise with No New Answers

cdc issues stricter vape warning than fdaThe CDC has begun recommending that people discontinue the use of any electronic cigarette or other device used for vaping until it can say, with some degree of certainty, what has been making people sick across the country and, in some cases, costing people their lives. This recommendation is a change from the FDA’s initial direction on the matter that specifically targeted illicit, street-purchased vape cartridges ...

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