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DC Trying to License Drug Reps

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The District of Columbia city council narrowly approves a bill to require drug salespeople to be licensed.

Info on Application Certifications Sent to OMB

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Federal Register Notice: FDA submits a collection of information on the certification for drug, biologic, and device applications ...

Merck Recalls 1.2 million Vaccine Doses

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Merck recalls over one million doses of its childhood vaccines PedvaxHIB and Comvax due to sterility concerns.

Asian Carbamazepine Patients Need Genetic Test

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FDA says labeling for carbamazepine will add a recommendation that patients of Asian ancestry be genetically tested before startin...

Deaths in RF Lung Tumor Ablation

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CDRH cautions healthcare providers about deaths associated with off-label use of RF ablation devices.

FDA Panel Backs Cardiome Drug

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FDAs Cardiovascular and Renal Drugs Advisory Committee votes to recommend approval of Cardiome Pharma Corp.s NDA for Kynapid, an i...

Merck, Schering-Plough Back Off Vytorin Changes

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Reps. Dingell and Stupak ask Merck and Schering-Plough CEOs why they planned to change a Vytorin trial endpoint.

FDA Sets DTC Fees

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Federal Register Notice: FDA establishes the FY 2008 fees that will be charged for each advisory review submission to FDA on DTC T...

Latest FDA Warning Letters

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In its latest batch of Warning Letters FDA cites E Med Future, International Technidyne, and Precision Biometrics.

Gambro Apheresis System Tubing Recalled

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Gambro BCT recalls its disposable tubing sets used with the COBE Spectra Apheresis System, Trima and Trima Accel Automated Blood C...