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Bundled Dialysis Rate Too High: GAO

[ Price : $8.95]

The Government Accountability Office says the Centers for Medicare and Medicaid Services probably paid too much in its 2011 bundle...

Ortho-Clinical Diagnostics Recalls 3 Types of Gel Cards

[ Price : $8.95]

FDA says that Ortho-Clinical Diagnostics is recalling specific lots of three types of gel cards made by Micro Typing Systems due t...

Info on Tobacco Industry Meeting Guidance Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a guidance on ...

Pfizer Pays $43 Million Over Antibiotic Marketing

[ Price : $8.95]

Pfizer agrees to pay $43 million to 33 states to resolve a multistate fraud investigation into the companys alleged unlawful promo...

Guidance on Product Design Safety Considerations

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Federal Register Notice: FDA releases a draft guidance, Safety Considerations for Product Design to Minimize Medication Errors.

Device Product Name Corrected

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Federal Register Notice: FDA makes a correction to a product name in a 12/7 Federal Register notice for the NeuroPace RNS System.

FDA Accepts Modular PMA Shell for Intercept Plasma

[ Price : $8.95]

FDA accepts a Cerus Corp. modular PMA shell proposal for the Intercept Blood System for plasma.

Guidance Out on Design Considerations for Home Use Devices

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Federal Register Notice: FDA releases a draft guidance, Design Considerations for Devices Intended for Home Use.

Jail Terms Needed in Health Fraud Cases, Blumberg Says

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FDA deputy chief counsel for litigation Eric Blumberg calls for greater use of the Park Doctrine and jail terms in healthcare frau...

Ethicon Hemostatic Matrix Recall is Class 1

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FDA says an Ethicon recall of Surgiflo Hemostatic Matrix products due to a packing process issue is Class 1.