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HHS Putting Out Guidance on Healthcare Program Exclusions

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HHS Office of Inspector General says an updated guidance on its healthcare program exclusion authority against industry execs will...

FDA Gives GlobalNet $29 Million for Computer Services

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FDA awards a five-year, $28.8 million contract to GlobalNet Services to provide operations and maintenance support for the agencys...

Mylan Settles Patent Battle on Generic Orapred ODT

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Mylan enters into a settlement agreement with Shionogi and CIMA Labs to end patent litigation related to a generic copy of Shionog...

Interoperability Challenges Explored

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An Association for the Advancement of Medical Instrumentation/FDA summit produces recommendations for improving interoperability w...

CMS Problems in Medical Identity Theft Response

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The HHS Inspector General recommends ways the Centers for Medicare and Medicaid Services can improve its response to medical ident...

Patients, Consumers Want PMA for Shortwave Diathermy Devices

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Patient and consumer groups voice opposition to a request that FDA reclassify shortwave diathermy devices to Class 2.

Cell Structure Study Can Lead to New Medicines

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Brookhaven National Laboratory researchers say their discovery of a molecular sled inside cells may lead to development of new ant...

FDA Chimes in on Comparative Effectiveness Data in Promos

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FDA says comparative effectiveness findings obtained from an observational study cannot be used in advertising or promotional mate...

NIH Workshop Wants Changes in Animal Study Design, Reporting

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A National Institute of Neurological Disorders and Stroke workshop recommends ways to improve animal study design and reporting.

Janssen Looking at Innovative Manufacturing Solution for Doxil

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Johnson & Johnsons Janssen drug unit explores an innovative collaboration with a new supplier to resolve an existing drug shortage...