Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were ...

While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are ...

The website changes raise concerns about “the interference of politics with the study and the practice” of science and ...

Valencia-based Avita Medical Inc. has received FDA approval for a version of its second-generation Recell skin cell ...

In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued ...

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: ...

Brenner, who worked in the FDA’s Center for Devices and Radiological Health, will take the helm of the agency until a new ...

Beckman Coulter Diagnostics, a global leader in clinical diagnostics, today announced the U.S. Food and Drug Administration ...

The U.S. Food and Drug Administration has pulled draft guidance from its website requiring companies to test medicines and ...

By establishing coding and separate payment for certain digital mental health devices, this group from CMS and the FDA hopes ...