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Democratic Platform Silent on FDA

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The Democratic 2012 platform is silent on any changes to be made to FDA.

Lilly Releases Glucagon Mobile App

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Lilly Diabetes releases a free app for Glucagon users and their support network.

Budget Sequestration Projected to Cut $300 Million at FDA

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The Alliance for a Stronger FDA projects 2013 budget cuts under Congress sequestration could deliver a devastating blow to FDA and...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Boukhari Prince Medical BPM, Commed, DPT Lakewood, Infupharma, Merge Healthcare,...

FDA Approves Higher Dose Exelon Patch

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FDA approves a higher dose of Novartis Exelon Patch (rivastigmine transdermal system) for treating people with mild to moderate Al...

QS Problems Seen in French Catheter Manufacturer

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FDA warns Prince Medical about Quality System and Medical Device Reporting violations in its French diagnostic catheter manufactur...

Violations Found in DPT Lakewood Inspection

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FDAs New Jersey District Office warns DPT Lakewood about CGMP violations in its manufacturing of Santyl ointment.

R&D Costs Up, Results Down: Study

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GBI Research says that companies are spending more on research and development but have fewer new products to show for it.

Aloxi Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Helsinn Healthcares Aloxi capsules, 0.5 mg (base) were not withdrawn for reasons of s...

Orphan Drug Act Evolves with FDA Changes: Attorneys

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A client alert from Washington, DC-based attorneys highlights evolving FDA policy developments under the Orphan Drug Act.