The European Commission now seems to routinely extend the list of carcinogenic, mutagenic, or reprotoxic (“CMR”) substances that are prohibited for use in cosmetics throughout the EU. Most of these banned substances are relatively unknown, but a grow…
Foreword by Julie Ross, International Business Development Director at Sedgwick: Welcome to the latest edition of spotlight. Spotlight is our way of sharing insights and perspectives from our strategic partners – lawyers, insurers, risk managers and…
Following a steady increase in reported deaths caused by faulty children’s products, the Consumer Product Safety Commission (CPSC) is under pressure to act more aggressively in pushing companies to recall products that pose a risk to children and tod…
Foreword by Julie Ross, international business development director at Sedgwick: Welcome to the latest edition of spotlight. Spotlight is our way of sharing insights and perspectives from our strategic partners – lawyers, insurers, risk managers and…
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…
For years, the European Commission has been working on a plan to create a circular economy for a more sustainable future. The resulting Circular Economy Action Plan (CEAP), adopted in March 2020, includes several strategic initiatives that would tran…
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…
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…
It may seem like everyone you know is driving an electric vehicle (EV) or is planning to buy one in the near future. On the contrary, adoption of EVs in the United States is very low – lower than in other major markets like China and Europe. Despite …
The global semiconductor shortage has plagued many industries and frustrated consumers for the best part of two years. To avert future shortages, the European Union (EU) has now joined the ranks of several countries in introducing legislation to shor…
As we enter the third calendar year of the COVID-19 pandemic, regulators are adapting to the “new normal.” As reported in our latest edition of the recall index report, product recalls rose by over a quarter (25.5%) across key European industries in …
While regulators and business leaders enter the third calendar year of COVID-19, some new challenges are emerging atop the lingering supply chain and service issues brought on by the pandemic. The Biden administration continues to push for more consu…
The European Union Clinical Trial Regulation (CTR) recently came into force and introduced a unified regulatory regime that applies to all EU member states. While the goal of the CTR is to reestablish the EU’s competitiveness in the field of scientif…
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…
The European Union’s “New Deal”, the Enforcement and Modernisation Directive, boosts consumer rights protection and updates e-commerce and digital content regulations. The directive also broadens the definition of product safety to include misleading…