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Report alleges the company did not begin a formal investigation until 2019, nine years after the first complaints and three years after company tests showed problems. Read More
Citing a continued dramatic growth in the use of laboratory-developed tests (LDT) over the past two decades, the FDA Friday announced a proposed rule that would bring the tests under the agency’s purview, trying a new route to put to rest the decades-long debate over who should provide oversight. Read More
A government shut down as of midnight on Saturday — the end of the fiscal year — appears likely as partisan disagreements about federal discretionary spending rage on with no clear end in sight. Read More
The FDA has provided further direction on developing therapies for graft-versus-host diseases (GvHD), technical considerations for devices with physiologic closed-loop controls, electronic De Novo requests, and breakpoints in labeling for antimicrobial susceptibility test system devices, issuing four new guidances. Read More
The frequent electronic exchange of health data through wireless, internet and networks along with the cybersecurity threats and vulnerabilities is driver for an FDA final guidance making recommendations for cybersecurity information to be submitted with premarket applications to CDRH and CBER. Read More
The FDA has deemed Hamilton Ventilators’ recall of its C1, C2, C3, T1 ventilators as class I, as the company has received reports of software issues that may cause the ventilators to stop without notice, with the potential for serious injury or death. Read More
As lawmakers fail to reach a deal to extend funding past the critical deadline of Sept. 30, the possibility of a government shutdown looms, threatening operations at the FDA and other government agencies. Read More