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9 Lots of Isovue Syringes Recalled

[ Price : $8.95]

Bracco Diagnostics recalls nine lots of Isovue pre-filled syringes due to the presence of visible particles.

FDA Accepts Aveo/Astellas NDA for Tivozanib

[ Price : $8.95]

FDA accepts an Aveo Oncology and Astellas Pharma NDA for tivozanib, indicated for treating patients with advanced renal cell carci...

Endo Urges Quick Action on Opana ER Withdrawal Petition

[ Price : $8.95]

Endo asks FDA to act quickly in determining that its non-crush resistant Opana ER was withdrawn from the market for reasons of saf...

Forest Labs Files NDA for Schizophrenia/Bipolar Drug

[ Price : $8.95]

Forest Laboratories submits an NDA for cariprazine, indicated for treating schizophrenia and manic or mixed episodes associated wi...

OIG Could Modify Corp. Integrity Agreements: Law Firm

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Ropes & Gray attorneys say two HHS Inspector General roundtables this year on pharmaceutical company compliance with corporate int...

FDA Lists Enforcement Actions Against 17 Drug Classes

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FDA reports on enforcement actions taken against 17 classes of unapproved new drugs.

HHS Inspector General Claims $6.9 billion in Recoveries

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The HHS inspector general says it has recovered about $6.9 billion through FY 2012 investigations and audits.

Sklamberg to Head CDER Office of Compliance

[ Price : $8.95]

CDER director Janet Woodcock says Howard Sklamberg will become director of the Centers Office of Compliance early next year.

FDA Clears AtCor Medical Blood Pressure Device

[ Price : $8.95]

FDA clears an AtCor Medical 510(k) for its SphygmoCor XCEL device, a new blood pressure cuff-based system that allows brachial and...

Quality, Reporting Problems Found at Nexera

[ Price : $8.95]

FDAs Florida District Office warns Nexera Medical about Quality System and Medical Device Reporting violations in its manufacturin...