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Cumberland Pharma Sues FDA Over Generic Acetadote

[ Price : $8.95]

Cumberland Pharmaceuticals files a lawsuit against FDA challenging the agencys decision to deny a citizen petition and approve Inn...

FDA Clears Quantel Ophthalmic Laser

[ Price : $8.95]

FDA clears a Quantel Medical 510(k) for its SupraScan 577 Laser, an ophthalmic laser system for treating a wide range of retinal d...

Panel to Discuss CoAxia NeuroFlo Catheter Device

[ Price : $8.95]

Federal Register Notice: FDAs Neurological Devices Panel will meet 12/10 to discuss the safety and effecitiveness of the CoAxia Ne...

Compliance Guide on OTC Bronchodilator Labeling

[ Price : $8.95]

Federal Register Notice: FDA releases a compliance guidance for small businesses on labeling for OTC bronchodilators.

AcelRx Pain System Meets Primary Endpoint

[ Price : $8.95]

AcelRx Pharmaceuticals reports that a Phase 3 study of its ARX-01 sublingual Sufentanil NanoTab PCA (patient-controlled analgesia)...

FDA Clears Semprus Bio Vascular Access Catheter

[ Price : $8.95]

FDA clears a Semprus BioSciences 510(k) for its vascular access catheter, Nylus Peripherally Inserted Central Catheter with Sempru...

FDA Panel Mixed on Heplisav Vaccine Effectiveness and Safety

[ Price : $8.95]

An FDA advisory committee votes 13 to 1 that a Dynavax Technologies BLA for Heplisav hepatitis B vaccine adequately demonstrated i...

Balance Transparency with Personal, Commercial Privacy: EFPIA

[ Price : $8.95]

The European Federation of Pharmaceutical Industries and Associations says steps must be taken to balance transparency with person...

Company Wants Supreme Court Decision in Sulindac Warning Case

[ Price : $8.95]

Mutual Pharmaceutical says the Supreme Court should resolve a split among appeals courts on whether its failure-to-warn preemption...

FDA Finds Potential Factor in IGIV Infusion Thrombosis

[ Price : $8.95]

FDA says it has identified a factor in some lots of immune globulin intravenous from several manufacturers that may increase the r...