Since the start of the COVID-19 pandemic, the FDA has had to adjust its approach to in-person inspections. The agency is now taking advantage of the available technologies to maintain high-level regulatory oversight remotely.  Read More

Creating an effective quality system (QS) requires a significant investment of time and resources. This requires more than just participation from staff. Management's involvement is key to setting up and maintaining a robust QS.  Read More

Product recalls are an unfortunate part of any manufacturing industry. For medical devices and pharmaceuticals, recalls are serious affairs requiring swift corrective action. Each year, an average of 4,500 drugs and devices are removed from the market due to recall. In 2017, the FDA identified more than 30 Class I recalls, where further use of the product could result in serious injury or death.... Read More

In a move that pharmaceutical companies are sure watch closely, Ohio Attorney General Mike DeWine officially filed a lawsuit on May 31 against Purdue Pharma L.P., Johnson & Johnson, Teva Pharmaceutical Industries Ltd., Allergan PLC, and Endo International PLC’s Endo Health Solutions Unit. The suit alleges that the practices of these companies, particularly their marketing of opioid pain killers,... Read More

In 2016, the ever rising cost of healthcare generated some of the most intense public and political debates. Perhaps in no way was this better summarized than the sudden – and shocking – rise in the price of the EpiPen, a life-saving device dispensing epinephrine for the severely allergic. From a price of $100 in 2007, the cost skyrocketed to over $600 last summer. Consumers were outraged,... Read More