With the US Food and Drug Administration’s (FDA) September 9, 2025 announcement that it will increase its enforcement of the Federal Food, Drug, and Cosmetics Act (FFDCA), its rules governing ...

The US Food and Drug Administration (FDA) held a 2-day public hearing this week to solicit input about the marketing and use of medications and medical devices for off-label use. It is fairly common ...

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...

The majority of medical and surgical devices used to treat children are not cleared by the Food and Drug Administration for use in pediatric populations, according to a new report from the American ...

In the highly regulated field of medical device labeling translation, ensuring that every translated word meets both linguistic and regulatory requirements is critical. A company specializing in ...