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Guide on Guidewire Testing and Labeling

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance on coronary, peripheral, and neurovascular guidewire testing and lab...

Final Guide on IVDs in Oncology Trials

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Federal Register notice: FDA makes available a final guidance entitled Investigational In Vitro Diagnostics in Oncology Trials: St...

FDA Clears OraSures Ebola Test

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FDA grants a de novo clearance for OraSure Technologiess OraQuick Ebola Rapid Antigen Test to detect Ebola virus antigens in human...

Comments on Inactive Ingredient Database Guidance

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Four stakeholders comment on an FDA draft guidance on its inactive ingredient database.

UTC Laboratories Settles FCA Charges for $42.6 Million

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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...

ICU Recalls Infusion Sets Over Leak Issue

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ICU Medical recalls certain lots of Plum and Sapphire Microbore Infusion Sets with inline filters due to the potential for fluid l...

Challenges of N-of-one Medicine: Woodcock, Marks

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FDAs CDER and CBER directors look at the many regulatory, ethical, and societal issues raised by developing drugs to treat a singl...

Clarus Wants FDA Testosterone-Ester Guidance

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Clarus asks FDA for written guidance on safety and efficacy standards needed for approval of an application for oral testosterone-...

2 Final Coronary Guidances Out

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FDA releases final guidances on device labeling for intravascular catheters and other devices and on guidewire performance tests a...

In Vitro Diagnostic Submission Streamlined Guidance

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FDA issues a guidance on a streamlined submission process for oncology investigational IVDs.