Frustration with the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) continues to mount among industry stakeholders over a lack of quick and economical regulatory approval processes. Since the inaction has resulted in s…
In late August, UK Members of Parliament criticised the UK government for failing to lead in regulating artificial intelligence (AI). The criticism came ahead of an AI summit the UK government is hosting in November, and followed the release of a gov…
In recent years, we have seen an increase in claims across Australia made by electricity distributors for financial loss resulting from third-party damage to their infrastructure. The most significant part of these losses commonly relates to a regula…
Contributing experts: Jeff Byxbe, senior risk services consultant and Michael Dougherty, director, risk services As is expected for the tenure of a Democratic president, the U.S. Department of Labor’s Occupational Health and Safety Administration (…
In early August, the government of the United Kingdom released 13 proposals to change product safety. While stakeholders have been expecting these proposals for a while now, a few of the changes came as a surprise to regulatory experts because they c…
The U.S. National Highway Traffic Safety Administration (NHTSA) indicated that it plans to publish a notice of proposed rulemaking on automated driving systems (ADS) this fall. Simultaneously, several members of the U.S. House of Representatives are …
This may be hard to believe, given that it’s now outlawed due to its adverse impact on human health, but asbestos was once considered a “miracle mineral.” Because asbestos is abundantly available and has some industrially useful properties, it was ve…
As technology rapidly evolves, cybersecurity has become indispensable in many industries. As the risk of cyberattacks infiltrates the healthcare industry, U.S. Congress is pressured to take action. As a range of medical devices — IV pumps, MRI …
On July 6, the U.S. Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released an updated list of draft and final guidance topics that will be a priority for the …
A little over a year ago, we published a blog on the topic of physician dispensing and how this practice has drastically increased pharmacy spend in workers’ compensation claims across a number of jurisdictions. The states most heavily impacted are f…
The U.S. Consumer Product Safety Commission (CPSC) has long prioritized protecting children’s safety as it relates to the use of consumer products, and that commitment is clear with the agency’s recent activity around secondary markets. Latest devel…
Strong relationships and trustworthy support are indispensable in today’s economic environment. Organizations need partners who can supplement their expertise and help them resolve complex issues. When choosing a vendor partner, it’s important for an…
Data from the first quarter of 2023 shows that product recalls across the U.S. automotive, consumer product, food and beverage, medical device, and pharmaceutical industries increased 14.2% from the previous quarter. As reported in Sedgwick brand pro…
European product recalls increased 6.1% in the first quarter of 2023, according to Sedgwick brand protection’s latest European recall index report. In total, the European automotive, consumer product, food and beverage, pharmaceutical, and medical de…
There are signs that the supply chain issues we’ve all witnessed over the past several years have started to subside, offering relief to many. That said, the pharmaceutical industry isn’t entirely out of the woods just yet. Supply chain setbacks have…