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Posts related to ‘pharmaceutical recall’

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June 22, 2021
Chris Harvey
VP, crisis solution
Expect regulatory scrutiny and product recalls to soar after COVID pandemic

As the post-COVID-19 world begins to reopen, we’re starting to find our way back to normalcy. But regardless of how quickly the entire country returns to "business as usual", risks to brand reputations are likely to increase as regulators resume work…

June 22, 2021 by Chris Harvey, VP, crisis solution
Blog
September 23, 2020
Amanda Combs
recall consultant
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 th…

September 23, 2020 by Amanda Combs, recall consultant
Blog
September 17, 2020
Chris Harvey
VP, crisis solution
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 reach…

September 17, 2020 by Chris Harvey, VP, crisis solution
Blog
June 01, 2020
Chris Harvey
VP, crisis solution
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 work and…

June 01, 2020 by Chris Harvey, VP, crisis solution
Blog
March 18, 2020
Amanda Combs
recall consultant
Future cost of COVID-19 on pharma manufacturers

As the number of COVID-19 cases continues 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 ma…

March 18, 2020 by Amanda Combs, recall consultant
Blog
November 13, 2019
Chris Harvey
VP, crisis solution
Product recalls stabilize, but an upsurge is expected

While U.S. product recalls were relatively flat from the second to the third quarter, expect an upsurge in the weeks and months to come as regulators – under growing pressure from Congress and consumer groups – turn their attention to currently unreg…

November 13, 2019 by Chris Harvey, VP, crisis solution
Blog
April 23, 2019
Chris Harvey
VP, crisis solution
Birth of a recall

When a consumer’s smartphone spontaneously combusts, the word-of-mouth news spreads to millions within days if not hours. If a certain blood pressure medicine is contaminated with a potentially cancer-causing agent, it could take months before routin…

April 23, 2019 by Chris Harvey, VP, crisis solution
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