It was early November. The Food and Drug Administration had just endured the high-profile, dramatic exit of its top drug ...

But the bigger picture, the former FDA leaders argued, is that the new proposals would reject long-standing science about how ...

The U.S. Food and Drug Administration (FDA) recently issued final guidance entitled “Conducting Remote Regulatory Assessments,” which explains the agency's plans to continue utilizing its records ...

With healthcare cyber attacks on the rise, the Food and Drug Administration is shifting its concern to a largely untargeted, yet vulnerable, area: medical devices. Here are six things to know. 1. The ...

Under FDA’s conditional approval pathway, the agency determined the product is safe and has a reasonable expectation of effectiveness for its intended use. Intervet Inc., based in Rahway, New Jersey, ...

Jan. 20-21 the Food and Drug Administration will host the “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity” public workshop to bring stakeholders together for discussion on ...

Based on medical device cybersecurity predictions from the beginning of 2025, let's revisit what was expected to shape the ...

In October, the U.S. Food and Drug Administration (FDA) for the first time ever issued an Emergency Use Authorization (EUA) for a drug to treat dogs and puppies infected with the parasite New World ...