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Enhanced Communication Team Works with Drug Sponsors

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FDA publishes a PDUFA notice on the work of the CDER enhanced communication team.

Forest, Ademas to Develop Fixed Dosed Alzheimers Treatment

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Forest Laboratories and Adamas Pharmaceuticals enter into an agreement to develop a fixed dosed combination of Namenda XR and done...

FDA Publishes Notice of FDA User Fee System Records

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Federal Register Notice: FDA publishes notice of a system of records entitled, FDA User Fee System, HHS/FDA.

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.

Opana ER Reducing Abuse, Endo Says

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

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.