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…
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,…
Reports indicate that the European Commission’s proposed overhaul of the EU’s general legislation on medicines for human use was rejected by the Regulatory Scrutiny Board, sending it back to the Commission for revision. The Commission was originally…
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…
From higher prices at the gas pump to increased costs at the grocery store, we’re all feeling the effects of inflation. Many of the proposed solutions — like fixing supply chain disruptions, increasing computer-chip production, and raising inte…
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…
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…
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…
Imagine a drug that will take you on a mystical experience where you can ride a dragon or touch the stars, but imagine the same drug can suffocate you under quicksand or imprison you in a sea of volcanic ash. These experiences are not through the mec…
Just over 40 years ago, the New England Journal of Medicine published a five-sentence letter to the editor [1] that would be used to ignite one of the worst public health tragedies of our time. Written by a Massachusetts physician and graduate studen…
Kathy Shostek, Vice President Healthcare Risk Management contributed a recent post about the management of drug samples in physician offices. The blog outlined the need for strategies for documentation and management of drug samples for reducing ri…