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Santarus Travelers Diarrhea Drug Meets Primary Endpoint

[ Price : $8.95]

Santarus Inc. reports positive Phase 3 data in evaluating rifamycin SV MMX, indicated to treat travelers diarrhea.

Transcept Pharma Begins Phase 2 OCD Study

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Transcept Pharmaceuticals completes enrollment in a Phase 2 clinical trial evaluating TO-2061 (ondansetron) as adjunctive therapy ...

New Study Challenges Daily Treatment for Asthmatics

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A new study finds that mild-to-moderate asthma sufferers using a low-dose inhaled corticosteroid daily fared no better than those ...

National Surveillance System Runs Risk of Being a Burden: Stakeholders

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Stakeholders at an FDA public meeting on Strengthening the National Medical Device Postmarket Surveillance System caution that bui...

CDERs Evolving Benefit-risk Framework for Optimal Reviews

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A CDER official describes the development and purpose of an evolving benefit-risk framework to be used internally by review staff ...

FDA Boosts its Ability to Handle Large Health Emergencies

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FDA tells science writers that the past two years have brought a dramatic increase in the agencys ability to respond to public hea...

FDA, Cold Genesys Agree on Bladder Cancer Drug SPA

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FDA and Cold Genesys reach agreement on a special protocol assessment for a Phase 2/3 trial of the companys CG0070 for non-muscle ...

MDR Concerns at Kimberly-Clark Plant

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FDAs Atlanta District Office warns Kimberly-Clerk about Medical Device Reporting violations at its Roswell, GA, manufacturing faci...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Apia Enterprise, bioMerieux, Generic Medical Devices, Global Biotechnologies, Gr...

Annual Device Imports Now Equal 8 Million Line Items: FDA

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CDRH Office of Compliance branch chief Daniel Walter says imported medical devices and related components continue to increase and...