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Santarus to File NDA for Ulcerative Colitis

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Santarus plans to file an NDA with FDA in the second half of 2011 due to positive results from a Phase 3 European trial of budeson...

FDA Accepts Glaxo Resubmission on Horizant

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FDA accepts for review a GlaxoSmithKline response to an earlier agency-issued complete response letter on an NDA for Horizant (gab...

Most Required Post-marketing Studies on Schedule: FDA

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FDA says the vast majority of required post-marketing studies are proceeding on schedule.

American Regent Recalls Lot #0491 of Magnesium Sulfate Injection

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American Regent voluntarily recalls one lot of its magnesium sulfate injection USP 50% (25g/50mL) due to the appearance of discolo...

House Committee Examines FDA Oversight of Puerto Rico Facilities

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The House Oversight and Government Reform Committee asks FDA for inspection records for all drug manufacturing facilities in Puert...

FDA Clears IOLMaster 500 for Cataract

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FDA clears a Carl Zeiss Meditec 510(k) for the IOLMaster 500, a biometer used to calculate all necessary eye measurements for cata...

FDA Clears Cook Medical 510(k) for Esophageal Stent

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FDA clears a Cook Medical 510(k) for the Evolution Controlled Release Esophageal Fully Covered Stent for use in esophageal cancer ...

Gene Therapy, Stem Cell Biology Make Gains

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An FDA conference on gene therapy and stem cell biology hears about significant increases in the number of trials, including 19 pe...

ISMP Calls for FDA Acetaminophen Action

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The Institute for Safe Medication Practices calls on FDA to make a thorough investigation of the risk of fatal overdose of acetami...

WalkMed Recalling Triton Pump

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FDA says WalkMed Infusion is recalling its Triton pole mount infusion pump.