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July 19, 2021
Chris Harvey
VP, crisis solution
CBD and cannabis: With opportunity comes risk

An exclusive life sciences webinar hosted recently by Sedgwick’s brand protection experts offered insight into the latest product safety challenges facing medical device, pharmaceutical and life sciences companies, including an insightful discussion …

July 19, 2021 by Chris Harvey, VP, crisis solution
Blog
June 02, 2021
Matt Walker
recall advisor
DOJ increasing enforcement on off-label promotion: Here’s what to expect

We’ve been warned. Recent settlements between the U.S. Department of Justice (DOJ) and several FDA-regulated drug and medical device manufacturers serve as a prelude to future DOJ enforcement activity involving off-label promotion. The DOJ and the U…

June 02, 2021 by Matt Walker, recall advisor
Blog
April 30, 2021
Amanda Combs
recall consultant
Revelations of another carcinogen in hand sanitizers puts more pressure on manufacturers

More than a year after the start of the COVID-19 pandemic, hand sanitizers are making headlines again. This time there are new revelations about the existence of high levels of the carcinogen benzene in sanitizers widely available to the public. An a…

April 30, 2021 by Amanda Combs, recall consultant
Blog
April 20, 2021
Amanda Combs
Embracing epidemiology in post-market surveillance

Women’s health products are facing increased regulatory scrutiny and epidemiology is the driving force behind pre-market and post-market surveillance. This evolution is driven by the premise that people of different biological sexes have unique respo…

April 20, 2021 by Amanda Combs
Blog
December 22, 2020
Ryan Gooley
Everything you need to know about the FDA’s proposed food traceability rule

The U.S. Food & Drug Administration (FDA) has issued a proposed rule to establish traceability recordkeeping requirements for certain foods. The proposal applies to those who manufacture, process, pack or hold foods designated for inclusion on the Fo…

December 22, 2020 by Ryan Gooley
Blog
December 04, 2020
Ryan Gooley
What the FDA’s new draft guidance means for food manufacturers

For years, undeclared allergens have been a leading cause of food recalls in the United States. And now, those fearful of facing blame for not doing enough to protect consumers are demanding quicker and broader food recalls. This month, The U.S. F…

December 04, 2020 by Ryan Gooley
Blog
December 01, 2020
Amanda Combs
recall consultant
Here’s what you need to know about fraudulent claims and phony COVID-19 products

From teas and essential oils to drugs, faulty masks, and other medical products, COVID-19 has brought a wave of deceptive marketing and fraud.Early on in the pandemic, the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC)…

December 01, 2020 by Amanda Combs, recall consultant
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
July 17, 2020
Chris Harvey
VP, crisis solution
Consider the FDA’s new food safety blueprint a warning

After months of COVID-19-related delays, the FDA has just released its “New Era of Smarter Food Safety: Blueprint for the Future.” Part of that blueprint focuses on recall modernization – a process that actually has been ongoing even without FDA’s cl…

July 17, 2020 by Chris Harvey, VP, crisis solution
Blog
July 17, 2020
Chris Harvey
VP, crisis solution
The FDA resumes its random inspections. Are you prepared?

The FDA recently announced that its inspectors may be knocking on your door as early as July 20 to conduct long-overdue domestic inspections. Once given the green light, inspectors’ first priority will be to conduct “mission-critical” inspections of …

July 17, 2020 by Chris Harvey, VP, crisis solution
Blog
July 10, 2020
Chris Harvey
VP, crisis solution
Hand sanitizers: Safe alternative to hand washing or deadly risk?

It may feel like COVID-19 is turning our lives upside down, sideways and backward 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 sh…

July 10, 2020 by Chris Harvey, VP, crisis solution
Blog
May 07, 2020
Dr. Teresa Bartlett, Senior Medical Officer, Sedgwick and Max Koonce, Chief Claims Officer, Sedgwick
Virtual Wellness ZENter: Medical marijuana, hazy health and cloudy compliance

Has it ever been more important to be mindful, stay present and set a clear path for health and wellness than it is right now? For this year’s RIMS 2020 conference, Sedgwick had planned to invite attendees to join us in the annual Wellness ZENter, a …

May 07, 2020 by Dr. Teresa Bartlett, Senior Medical Officer, Sedgwick and Max Koonce, Chief Claims Officer, Sedgwick
Blog
May 05, 2020
Ryan Gooley
Blue Bell: A cautionary tale for all food companies

News about Blue Bell Creameries’ guilty plea and $19 million in federal fines linked to a deadly 2015 listeria outbreak that led to a series of ice cream recalls serves as a cautionary tale for all food companies operating in today’s punishing media …

May 05, 2020 by Ryan Gooley
Blog
April 20, 2020
Ryan Gooley
Food recalls in the midst of the pandemic

Food means joy, comfort – and frankly, employment – for many. But these days, food has too often become synonymous with uncertainty, stress, and fear. As coronavirus began to spread in the U.S., consumers rushed to supermarkets to stock up on food…

April 20, 2020 by Ryan Gooley
Blog
March 27, 2020
Professional Liability Team, Sedgwick
Are you prepared? Healthcare and liability concerns during the coronavirus outbreak

As a claims organization, it’s up to us to keep our clients and their customers informed on current issues and deliver peace of mind. The healthcare, product liability and life sciences space is constantly evolving, but we’re keeping an eye on the fo…

March 27, 2020 by Professional Liability Team, Sedgwick
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