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FDA Evaluating Cancer Drugs on Pathological Complete Response

[ Price : $8.95]

FDA Office of Hematology and Oncology staffers Richard Pazdur and Tatiana Prowell say the agency has a new pathway for giving acce...

FDA Clears Covidiens HawkOne Atherectomy System

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FDA clears a Covidien 510(k) for the HawkOne directional atherectomy system.

Inspection Finds QS Problems at Xanacare Technologies

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The FDA Denver District Office warns Xanacare about Quality System and other violations in its manufacturing of the SimulCare II t...

CMS Exempts Medical Education from Sunshine Act Reporting

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The Centers for Medicare & Medicaid Services revises its reporting requirements under the Physician Payments Sunshine Act to exclu...

CNS Drugs Take Longer to Develop, Have Lower Success

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A Tufts Center for the Study of Drug Development analysis finds that central nervous system drugs take longer to develop and appro...

QS Violations Found in BioMerieux U.S. Facility

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FDAs Kansas City District Office warns BioMerieux about Quality System violations at its Hazelwood, MO, facility.

FDA Partially Approves Petition on Proton Pump Safety

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FDA partially approves a 2011 Public Citizen petition calling on FDA to require labeling changes to all proton pump inhibitors.

Biosimilars Could Save U.S. $44 Billion: Analysis

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A new RAND Corp. analysis says that biosimilar products have the potential to cut spending on biologics in the U.S. by $44 billion...

Richard-Allan Scientific Class 1 Recall of Tissue Preservative

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Richard-Allan Scientific begins a Class 1 recall of its 10% Neutral Buffered Formalin due to product concentration concerns.

FDA Study Finds Reduce Risks for Pradaxa Compared to Warfarin

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An FDA study finds that Boehringer Ingelheim Pharmaceuticalss Pradaxa (dabigatran etexilate mesylate) was associated with reduced ...