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Court Affirms Most of Shire Vyvanse Decision

[ Price : $8.95]

A federal appeals court backs a lower court decision on two key elements in a case involving disputed patents for Shires Vyvanse.

Many Devices Exposed to Online Hacking: Report

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UK researchers say many healthcare organizations are exposed to cyber hacking of their medical device systems.

FDAs Amarin Problems Traced to Caronia Decision

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Skadden attorneys say that FDAs failure to appeal its off-label promotion case in United States v. Caronia led to a federal judges...

Intersect ENT sPMA for Propel Sinus Implant

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Intersect ENT files a PMA supplement seeking approval to expand the indication of the Propel mini steroid releasing sinus implant ...

Rare Disease Clinical Trials Bill Heads to Obamas Desk

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The Ensuring Access to Clinical Trials Act of 2015 moves to president Obamas desk for signing after the House passed the measure 9...

Ortho Evra Transdermal System Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Ortho Evra Transdermal System was not withdrawn from sale for reasons of safety or ef...

Medsource Inspection Finds QS Violations

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FDAs New England District Office warns Medsource about Quality System regulation and other violations.

FDA Proposing New Intended Use Definition

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An Inside Medical Devices analysis says drug and medical device companies should consider and comment on a proposed regulation rev...

Industry Needs More Time for Analytical Control Strategies: GPhA

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The Generic Pharmaceutical Association says a significant investment of time and resources is required to establish an analytical ...

FDA Accepts Sanofi NDA for New Diabetes Drug

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FDA accepts for filing a Sanofi NDA for lixisenatide, an investigational once-daily prandial GLP-1 receptor agonist for treating a...