After largely pausing onsite facility inspections during the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) has resumed this type of oversight in the past 18 months. However, several recent in-market events involving contaminated eye …
The healthcare industry is changing to accommodate more modern demands, particularly those of patients who choose to self-treat. Over-the-counter (OTC) medications have risen in popularity recently, as patients increasingly seek more flexibility to t…
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…
Benzene, which has been discovered in several consumer products over the past year, has once again forced a voluntary recall. This time, it’s related to dry shampoo and dry conditioner spray products from various household brands. The recall is prec…
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’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…