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Tag: Product Safety

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 In 2019, the contaminant was found in ranitidine medications (commonly known as Zantac) and Nizatidine.

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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 injuries and death is a reminder of just how public a product safety issue can be – long before AND long after a company or regulator takes action to protect consumers.

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Jul
10

Hand Sanitizers: Safe Alternative to Hand Washing or Deadly Risk?

It may feel like COVID-19 is turning our lives upside down, sideways and backwards over the last few months. For some, it has made daily life downright scary. And now, when soaps, disinfectants, and cleaning products are still hard to find on store shelves, consumers need to be extra cautious of which hand sanitizers they use. The FDA recently warned consumers to avoid certain brands of hand sanitizer for fear they are contaminated with methanol.

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Jun
18

The CPSC’s New Ombudsman Can Be Useful to Manufacturers Who Pay Attention

The Consumer Product Safety Commission (CPSC) is continuing full steam ahead despite the coronavirus pandemic, recently announcing Dr. Jonathan Midgett as its appointed Consumer Ombudsman. According to the CPSC, the Consumer Ombudsman is a new position created to “give consumers a greater voice and understanding of the agency and its activities.

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Jun
15

Expert Insight from Exponent

Exponent, Inc. is a multi-disciplinary engineering and scientific consulting firm that brings together more than 90 technical disciplines to solve engineering, science, regulatory, and business issues for its clients.

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