District Judge John Bates wrote the removals harm “everyday Americans, and most acutely, underprivileged Americans, seeking ...
Scott Gottlieb supports a reversion to an earlier interpretation of the 21st Century Cures Act, which would exempt more types of clinical decision support software from the FDA’s premarket review ...
FDA’s Rare Disease Innovation Hub Releases Strategic Agenda: Implications for Stakeholders in 2025
In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed ...
Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...
Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading key policies on artificial ...
The head of the FDA’s artificial-intelligence-focused Digital Center of Excellence, Troy Tazbaz, is departing the agency ...
The FDA says the cybersecurity vulnerabilities identified may put patients at risk when the device is connected to the internet.
The U.S. Food and Drug Administration has approved Journavx (suzetrigine) 50 milligram oral tablets, marking the introduction of a first-in-class non-opioid analgesic designed to treat moderate to ...
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