Posts Tagged 'FDA'

Recalls Urged Over Hand Sanitizer Contamination

Online pharmacy Valisure is in the news once again as its ongoing product testing has revealed high levels of benzene in a number of brands of hand sanitizer currently on the market and available for sale.

Valisure’s policy of independently testing the products it sells for purity and contamination initially came to light after it discovered elevated levels of NDMA in heartburn medication Zantac. News of the find came long before the issue had found its way onto the FDA’s ...

continue reading...

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fda drug side effect database outdated and inaccurateA new report out of the Milwaukee Journal Sentinel calls attention to the fact that the FDA’s tracking of drug side effects; many of them dangerous, has been out of date, underreported, and inaccurate for upward of 60 years.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

continue reading...

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 ...

continue reading...

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 ...

continue reading...

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 ...

continue reading...

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 ...

continue reading...
Page 4 of 21 «...23456...»