In the wake of a significant recall of applesauce pouches, renewed attention has been drawn to the U.S. Food and Drug Administration’s (FDA’s) food contamination regulatory powers – or the lack thereof. In late October 2023, the FDA issued a safety …
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 …
Responding to stakeholder concerns, the U.S. Food and Drug Administration (FDA) announced that it will establish a one-year stabilization period for the Drug Supply Chain Security Act (DSCSA) traceability requirements to ensure continuity of the supp…
As technology rapidly evolves, cybersecurity has become indispensable in many industries. As the risk of cyberattacks infiltrates the healthcare industry, U.S. Congress is pressured to take action. As a range of medical devices — IV pumps, MRI …
On July 6, the U.S. Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released an updated list of draft and final guidance topics that will be a priority for the …
The U.S. veterinarians’ market is booming thanks in part to the growing popularity of animal adoption (and in turn, wider use of pet insurance and expenditure on pet well-being). According to Grand View Research, the U.S. vet market was valued at jus…
Regulators in the United States have been moving especially quickly in the past year to implement new rules to protect children. With 2023 now well underway, companies should expect even more regulatory changes as federal agencies update their langua…
As the medical imagining sector continues to rapidly grow, so do the risks of malfunction and catastrophic failure in its technology. Imaging equipment manufacturers are the primary service providers for equipment repairs, however, there can be a wid…
The statistics regarding drug use among the American workforce are alarming. An estimated one in 12 U.S. workers has a substance use disorder (SUD), and more than half of all adults diagnosed with an SUD are employed full-time. Many more members of t…
The Food and Drug Administration (FDA) came under harsh criticism this past year after a commercial infant shortage formula in the U.S. For months, Congress and parent advocacy groups have been pressuring the agency to investigate why this crisis eru…
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…
More than 900 million units of vehicles, food, drugs, consumer products and medical devices were recalled during the first quarter of 2022. This is the highest number recalled in a single quarter over the past 10 years, as reported in our latest edit…
As COVID-19 begins to subside, the U.S. Food and Drug Administration (FDA), like other federal agencies is shifting its focus away from the pandemic and back toward more routine issues. As an example, the FDA recently published its final guidance out…
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…
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…