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Hamburg in Hot Seat at Drug Compounding Hearing

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Democratic senators and House Energy and Commerce Committee Republican members take aim at FDA in separate Hill hearings and criti...

FDA Rejects Xyrem ANDA Bioequivalence Request

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FDA denies a Jazz Pharmaceuticals citizen petition asking that it publish bioequivalence requirements for any ANDA for a generic f...

Hospira Holds Symbiq Pump Shipments

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Hospira tells the SEC it is suspending shipment of Symbiq infusion pumps to U.S. customers due to an FDA import alert.

QS Violations Found in Westone Labs Inspection

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FDAs Denver District Office warns Westone Laboratories about QS violations in its manufacturing of the Oto-Ease patient lubricant....

FDA Accepts Geno NDA for Nitric Oxide System

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FDA accepts for review a GeNO LLC NDA for GeNOsyl MVG-2000 Nitric Oxide Delivery System for neonates with hypoxic respiratory fail...

FDA Clears Cerner FetaLink Surveillance System

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FDA clears a Cerner 510(k) for its FetaLink+, a solution that provides clinicians access to maternal and fetal surveillance inform...

Ikaria Software Upgrade for Inomax Drug Delivery System

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FDA clears an Ikaria 510(k) for a software upgrade to enable connectivity of the Inomax DSIR drug delivery system with hospital he...

Group Wants Harmonized API Regs

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The European Fine Chemicals Group calls for global harmonization of active pharmaceutical ingredient rules and regulations.

FDA OKs Medtronics Valiant Captivia Stent for Aortic Injuries

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FDA approves Medtronics Valiant Captivia stent graft system for repairing blunt traumatic aortic injuries.

Opana ER Reducing Abuse, Endo Says

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Endo tells FDA that its reformulated Opana ER has reduced opioid drug abuse.