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Tag: pharmaceutical recall

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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Jun
01

Drug Recall Risks During – and After – a Global Pandemic

Until a few months ago, few if any senior executives had personal experience managing a company during a pandemic. Making matters more difficult, there’s really no recent history to consult to determine what perils lie ahead, which processes worked, which didn’t, and how to plan for a recovery once the crisis passes. Unfortunately, this uncertain environment seems likely to continue for the foreseeable future.

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Apr
06

Expert Spotlight on Barbara Blumenfeld & William Garvin

BARBARA A. BINZAK BLUMENFELD PH.D.Shareholder, Buchanan Ingersoll & Rooney Barbara’s Background Dr.

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Mar
18

Future Cost of COVID-19 on Pharma Manufacturers

As the number of COVID-19 cases continue to increase worldwide, numerous questions and a tremendous amount of misinformation cloud the issue. Many remain confused about how the virus is transmitted, how dangerous it is, and what treatments for it may be available. The good news is that the safety of our food has been given a clean bill of health so far. Research indicates that food and food ingredients aren’t a transfer source for coronavirus.

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