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April 18, 2022
Ryan Gooley
With the FDA’s latest recall guidance, mock recalls are now a must

As COVID-19 begins to subside, the U.S. Food and Drug Administration (FDA), like other federal agencies is shifting its focus away from the pandemic and back toward more routine issues. As an example, the FDA recently published its final guidance out…

April 18, 2022 by Ryan Gooley
Blog
April 05, 2022
Amanda Combs
recall consultant
High levels of nitrosamine causing recalls

Over the past few years, several drugmakers have had to recall blood pressure medications due to the presence of excess levels of nitrosamine. It’s happening again. Two major pharmaceutical companies have issued voluntary recalls of several tablet me…

April 05, 2022 by Amanda Combs, recall consultant
Blog
March 24, 2022
Chris Harvey
VP, crisis solution
FDA urges companies to be ‘recall ready’ as it releases finalized guidance

The U.S. Food and Drug Administration (FDA) recently finalized a guidance document outlining how companies and stakeholders should become “recall ready” to minimize buyers’ and users’ exposure to potential health risks.The Initiation of Voluntary Rec…

March 24, 2022 by Chris Harvey, VP, crisis solution
Blog
February 11, 2022
Matt Walker
recall advisor
FDA focuses on women’s health in medical device research and regulation

The US Food and Drug Administration (FDA) has turned its attention to the development and regulation of medical devices unique to women’s health. The FDA’s Center for Devices and Radiological Health (CDRH) recently finalized its Health of Women…

February 11, 2022 by Matt Walker, recall advisor
Blog
December 17, 2021
Matt Walker
recall advisor
New threat modeling playbook prepares medical devices for cybersecurity issues

Cybersecurity has become a critical issue for the medical device industry, where a cyber threat can lead to injury or even death. To address this growing problem, the U.S. Food and Drug Administration, the MITRE Corporation, and the Medical Device In…

December 17, 2021 by Matt Walker, recall advisor
Blog
December 13, 2021
Chris Harvey
VP, crisis solution
Regulatory, legal and reputational risks increasing for all businesses in 2022

We are living through a perfect storm of heightened business risks that are impacting every industry — from labor shortages, supply chain issues and inflation to increased regulatory oversight and enforcement. When combined, these risks pose su…

December 13, 2021 by Chris Harvey, VP, crisis solution
Blog
September 28, 2021
Matt Walker
FDA regulations for AI/ML-based medical devices expected soon on heels of EU MDR

Following the lead of the European Union and Great Britain, the U.S. FDA has begun rolling out its action plan for regulating artificial intelligence/machine learning (AI/ML)-based software as a medical device. The United Kingdom’s Medicines and He…

September 28, 2021 by Matt Walker
Blog
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
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