Thought Leadership

In a strongly-worded statement, the Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D. recently announced the agency is taking steps to curtail what it called the “epidemic” of e-cigarette use among teenagers. Among other actions, the FDA is looking closely at flavored e-cigarettes, saying they “play an important role in driving the youth appeal.” […]

Even when companies have a robust recall plan in place, preparing for a soon-to-be-announced recall is a stressful event. Companies must act quickly in order to satisfy regulatory mandates and mitigate risk. Here are four steps pharmaceutical companies should take to get ready for a recall: Ensure consignee data is up-to-date This is often one […]

It has been five years since the Food and Drug Administration (FDA) released a final rule establishing a unique device identification (UDI) system for the medical device industry. The benefits are numerous and include more accurate reporting of adverse events, a reduction in medical errors, and more effective management of medical device recalls. But UDI’s […]

Our Q2 2018 Recall Index found that recall activity in the food space increased in Q2, especially when it came to Food and Drug Administration (FDA) food units, which rose more than 20 times over the previous quarter to nearly 213 million, mostly due to one large recall of salmonella-contaminated eggs. But other measurements also […]

Many companies think that because they have a recall plan in place, they are ready for any recall that may occur, only to realize they are actually woefully unprepared when it actually happens. That typically points to one thing: the plan wasn’t nearly as robust as it needed to be. When it comes to recall […]