Aligned Medical Solutions recalls its custom convenience kits due to the potential for the plunger on the Cardinal Health Monoject Flush Prefilled Syr...
FDA grants Meridian Bioscience an emergency use authorization for its Revogene SARS-CoV-2 assay, a molecular diagnostic test for the qualitative detec...
The Justice Department says kalo is paying $12.7 million to resolve a whistleblowers allegations that it induced false claims for its Evzio anti-opioi...
FDA clears a Vektor Medical 510(k) for vMAP, a computational electrocardiogram mapping system for use to improve outcomes in ablation procedures.
Childrens Health Defense calls for a congressional probe of FDAs handling of a whistleblowers complaint about poor research practices at a contractor ...
Medical device regulatory consultant Adrienne Lenz says FDA needs to develop a way for medical device manufacturers to transmit electronic 510(k) subm...
The Justice Department says Arthrex is paying $16 million to resolve a whistleblowers allegations of kickbacks leading to False Claims Act payments.
Federal Register news: FDA determines for patent extension purposes the regulatory review period for Ultragenyxs Dojolvi (triheptanoin).