While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are ...
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 ...
Beta CEO Marcel Botha talks about the FDA’s plans for medical shortage notifications and how Trump’s policies may impact US ...
The website changes raise concerns about “the interference of politics with the study and the practice” of science and ...
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued ...
The FDA’s Webinar for Manufacturers and Other Interested Parties - The U.S. Food and Drug Administration (FDA) will host a webinar ...
Valencia-based Avita Medical Inc. has received FDA approval for a version of its second-generation Recell skin cell ...
As AI in the medical device space rises, it likely means 2025 will be another challenging year for cyber threats in ...
Brenner, who worked in the FDA’s Center for Devices and Radiological Health, will take the helm of the agency until a new ...
How the FDA and CMS worked together on a new approach to paying for digital mental health treatments
By establishing coding and separate payment for certain digital mental health devices, this group from CMS and the FDA hopes ...
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