News
WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...
1hon MSN
Beyond staff cuts, the departures of some longtime investigators in recent months have left less experienced people tasked ...
The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.
The Food and Drug Administration has published final guidance for the cybersecurity of premarket medical devices. The new ...
FDA's plan to phase out animal testing may hurt Charles River's revenues. The DCF model suggests that CRL presents an ...
Onward Medical announced today that it submitted its ARC-EX system for expanded FDA indication and for CE mark approval.
CytoSorbents Corporation (NASDAQ: CTSO), a leader in blood purification therapies for life-threatening conditions in the intensive care unit and cardiac surgery, today provided a regulatory update on ...
The FDA is notifying healthcare providers about import alerts for certain medical devices manufactured in Japan by Olympus.
The Food and Drug Administration is urging medical product makers to carefully address the cybersecurity of their connected ...
Endoscopy devices restricted from import accounted for about 1% of the company’s consolidated revenue in its latest fiscal ...
Federal authority to regulate cosmetics remained largely unchanged until, on December 29, 2022, President Biden signed the ...
The agency said it issued the import alerts because it “continues to have concerns related to outstanding Quality System ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results