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Endo Sues FDA Over Opana ANDAs

[ Price : $8.95]

Endo Pharmaceuticals sues FDA seeking declaratory and injunctive relief that will effectively block generic copies of Opana ERs no...

Biosimilar Paper Urges Distinct Naming Process

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A whitepaper from the Alliance for Safe Biologic Medicines (ASBM) urges FDA to require that all biosimilar and biologic products b...

Class 1 Recall of Mindray Anesthesia Devices

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FDA says Mindray has begun a Class 1 recall of its Mindray A3 and A5 Anesthesia Delivery System.

FDA Accepts Eisai NDA for AcipHex

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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...