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UTC Laboratories Settles FCA Charges for $42.6 Million

[ Price : $8.95]

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.

FDA Software Guidance Discussed

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Attorney Michelle Bufano discusses elements of the recent FDA guidance on medical software and apps.

Beckman Coulter Lab Automation Device Cleared

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FDA clears a Beckman Coulter 510(k) for the DxA 5000 total laboratory automation system.

Workshop on Pediatric Clinical Trial Endpoints

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Federal Register notice: FDA announces an 11/12 public workshop on patient perspectives in pediatric clinical trial endpoints for ...

Priority Voucher Awarded to Bavarian Nordic

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Federal Register notice: FDA announces that it has issued a material threat medical countermeasure priority review voucher to Bava...