According to our latest European product recall index report, the overall number of recall events in Europe fell 8.8% in the third quarter, compared to Q2. The pharmaceutical sector experienced the greatest decline, registering 25.0% fewer events. Th…
As supply chains become more disrupted ,regulatory environments more complex, and economic forecasts more uncertain than ever before, companies face increased product liability concerns and exposures. According to our latest U.S. recall index report,…
The total number of U.S. products recalled this year has now topped 1 billion, according to our latest U.S. product Recall Index. More than 1 billion units have been recalled only twice before in history, in 2018 and 2021. However, it took a full yea…
Even as many countries eased pandemic-related restrictions, recent events have introduced a new host of challenges and risks for the five key industries surveyed in our latest edition of the European Recall Index report. Our report includes analysis …
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…
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 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…
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…
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…
As we emerge from one of the most turbulent and uncertain times in recent history, consumers are eager for a return to normal and economists are predicting a boom as we approach the holiday season. But with so much uncertainty still ahead, it seems t…
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…
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…
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…
The global response to the coronavirus crisis put a bright spotlight on the complexity of global supply chains. But not only in the traditional, “behind-the-scenes” way we think about companies sourcing inputs, component parts and ingredients. It als…