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FDA Accepts Eisai NDA for AcipHex

[ Price : $8.95]

FDA accepts an Eisai Inc. NDA for AcipHex Delayed-Release Sprinkle Capsules 5mg and 10mg for Gastroesophageal Reflux Disease.

Supreme Court to Hear Generic Drug Preemption Case

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The U.S. Supreme Court grants a request to hear a pharmaceutical case involving a design defect and generic drug preemption.

FDA Panel Mixed on Theravances Vibativ Expanded Use

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FDAs Anti-Infective Drugs Advisory Committee votes down Theravances Vibativ (telavancin) for primary use in treating nosocomial pn...

Appeals Court Upholds Former Purdue Execs Exclusions

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The U.S. Court of Appeals for the District of Columbia Circuit denies a petition for rehearing from three former Purdue Frederick ...

CDRH Touts Device Review Improvements in New Report

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A new CDRH report highlights significant improvements seen with its pre-market approval program since revamping it two years ago a...

Merck Submits DTC Research on Dual Modality to FDA

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Merck submits DTC research to showing that dual modality presentation of information in DTC ads increases recall and understanding...

Is Hamburg Brave Enough to End the Plan B Ruckus?

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Washington commentator Robert F. Steeves says the post-election political climate is conducive to removing all age limits on OTC e...

Reinspect Warned Compounding Pharmacies: Public Citizen

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Public Citizen calls on FDA to immediately reinspect all compounding pharmacies that received Warning Letters in the past to ensur...

Guidance on Testing Preclinical Cell, Tissue, Gene Products

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CBER issues a draft guidance with recommendations for information needed to support clinical trials for investigational cell, tiss...

FDA Panel Backs J&J Tuberculosis Therapy

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FDAs Anti-Infective Drugs Advisory Committee unanimously votes to support efficacy findings with Janssen Research & Developments b...