Posts Tagged 'Food and Drug Administration'

FDA Tracking: What Good is a Database if the Data is Inaccurate?

fda drug side effect database outdated and inaccurateA new report out of the Milwaukee Journal Sentinel calls attention to the fact that the FDA’s tracking of drug side effects; many of them dangerous, has been out of date, underreported, and inaccurate for upward of 60 years.

Created in 1960, the system was devised as a way of tracking adverse drug events once the products received their clearance and made it to market. Based largely ...

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Clinical Drug Trial Inspections Lacking Under Trump Administration

trump administration responsible for drastic drop in corrective action by FDAIn the first three years of the Trump administration, a grand total of 12 letters were sent by the FDA to drug makers warning them over violations found in their clinical drug trials. The agency’s warning letters are sent when the FDA notes violations of practice, procedure, or in some cases, law. In contrast, the first three years of the Obama presidency saw 99 such letters sent, ...

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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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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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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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