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Sep
23

What The FDA’s Nitrosamine Impurity Guidance Means for Drug Manufacturers

It’s been over two years since carcinogenic nitrosamines were discovered in some widely used drugs. The discovery occurred in 2018 when the contaminant was found in active pharmaceutical ingredients in Valsartan, a blood pressure medication. Since then, the contaminant has been found in several other drugs taken by millions of people each year. The Latest Update […]

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Sep
17

Reputational Risk At An All-Time High As Recalls Continue Into The Third Quarter

COVID-19 may have stalled huge sectors of the global economy, but regulatory oversight in the U.S. remains vigilant and may even be picking up its pace as we move through the third quarter. In fact, medical device recalls in the second quarter reached levels we haven’t seen in two years, surpassing 300 recall events for […]

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Sep
09

This New App Can Improve Automotive Recall Effectiveness

In its effort to further enhance recall effectiveness, the National Highway Traffic Safety Administration (NHTSA) recently announced the launch of SaferCar, a free smartphone app that will notify drivers of recalls on their vehicles by simply inputting its information. It’s as easy as downloading the app and scanning the Vehicle Identification Number (VIN). After the […]

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Aug
18

Don’t Let Facebook and Twitter Posts Tell Your Product Safety Story

Thanks to social media platforms like Facebook and Twitter, adverse events – reports of injury, illness, death or product malfunction to name a few – are part of the public domain. This isn’t breaking news. But FDA’s release of a trove of social media posts linking Bayer’s contraceptive implant Essure with adverse events including serious […]

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Aug
07

Your “Excellent” Recall Crisis Plan May Damage Your Reputation, New Study Reveals

In their quest for excellence, many companies try to amaze their customers with superior products and even better service. More than a few have extended that philosophy to their crisis planning, offering free products, cash, generous coupons and other compensation to atone for the inconvenience consumers suffer in a product recall. But a new study […]

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