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The Justice Department says UTC Laboratories and its three principals will pay $42.6 million to resolve six whistleblower False Cl...[ Price : $8.95]
ICU Medical recalls certain lots of Plum and Sapphire Microbore Infusion Sets with inline filters due to the potential for fluid l...[ Price : $8.95]
FDAs CDER and CBER directors look at the many regulatory, ethical, and societal issues raised by developing drugs to treat a singl...[ Price : $8.95]
Clarus asks FDA for written guidance on safety and efficacy standards needed for approval of an application for oral testosterone-...[ Price : $8.95]
FDA releases final guidances on device labeling for intravascular catheters and other devices and on guidewire performance tests a...[ Price : $8.95]
FDA issues a guidance on a streamlined submission process for oncology investigational IVDs.[ Price : $8.95]
Attorney Michelle Bufano discusses elements of the recent FDA guidance on medical software and apps.[ Price : $8.95]
FDA clears a Beckman Coulter 510(k) for the DxA 5000 total laboratory automation system.