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Federal Register notice: FDA makes available a final guidance entitled Investigational In Vitro Diagnostics in Oncology Trials: St...[ Price : $8.95]
FDA grants a de novo clearance for OraSure Technologiess OraQuick Ebola Rapid Antigen Test to detect Ebola virus antigens in human...[ Price : $8.95]
Four stakeholders comment on an FDA draft guidance on its inactive ingredient database.[ Price : $8.95]
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]
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.