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Atrial Fibrillation Drug Trial Enrollment on Hold

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Cardiome Pharma and development partner Astellas Pharma have suspend patient enrollment in their ACT 5 study involving investigati...

HHS Inspector General Publishes Exclusion Guidelines

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The HHS inspector general publishes factors it will consider when determining whether to exclude individuals from participating in...

FDA is a Good Place to Work: Employee Survey

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A government-wide employee survey shows that FDA employees see the agency as a good place to work.

Travatan Z Convention Graphic is Misleading: DDMAC

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CDERs Division of Drug Marketing, Advertising, and Communications says a convention graphic for Alcons Travatan Z broadens the dr...

Actavis Recalls 18 Fentanyl Lots

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Actavis recalls 18 lots of Fentanyl patches after identifying one patch that released its active ingredient faster than specificat...

Mylan's Generic Mirapex Approved

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FDA approves a Mylan Pharmaceuticals ANDA for a generic version of Boehringer Ingelheim's Mirapex tablets, indicated for treating ...

Feds, States Probe Avandia and Other GSK Drugs

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GlaxoSmithKline says it is in the process of responding to a U.S. Department of Justice subpoena relating to the development and m...

Theravance Reports Positive Results from Constipation Studies

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Theravance reports positive topline results from a Phase 1 multiple-ascending dose study and a proof-of-concept Phase 2 study eval...

OGD Brings in Consultant to Tackle Generic Backlog

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CDER retains business-process consultant McKinsey & Co. to help it find a way out of its increasing backlog of pending generic dru...

FDA Clears Boston Scientifics Advanix Biliary Plastic Stents

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FDA clears a Boston Scientific 510(k) for the Advanix Biliary Plastic Stents for treating biliary strictures.