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Guidance on Devices Delivering OTC Liquid Drugs

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance on dosage delivery devices for OTC liquid drug products.

Panel to Discuss NDA for HIV Patients

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FDAs Endocrinologic and Metabolic Drugs Advisory Committee is tentatively scheduled in the first quarter 2010 to discuss Theratech...

FDA Clears Arkray Blood Glucose System

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FDA clears an Arkray, Inc. 510(k) for the GlucoCard Vital blood glucose monitoring system.

FDA Warns Against Impulsaria Stiff Nights Supplement

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FDA warns consumers not to use Impulsarias dietary supplement Stiff Nights because it contains an undeclared chemical similar to V...

Critical Path Chief Surprised by Slow Use of Bioinformatics

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FDA acting director of the Critical Path Initiative Leonard Sacks provides an update on critical path projects, but expresses surp...

Federal Court Rejects Preliminary Injunction in Tobacco Case

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A Kentucky federal court rejects a request for preliminary injunction sought by tobacco companies to prevent FDA from regulating c...

FDA Clears Spine Plate System

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FDA clears a Custom Spine 510(k) for the Regent ACP, an anterior cervical plate system.

FDA Launches Safe Use Initiative and Report

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Federal Register Notice: FDA launches its Safe Use Initiative and releases a report on the initiative and the collaboration to red...

FDA Grants Orphan Status for Abraxane

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FDA grants Abraxis BioScience an orphan drug designation for its chemotherapy agent Abraxane injectable suspension, proposed for t...

Centurion Recalls Premie and Meconium Packs

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CDRH says that Centurion Medical Products is recalling its Premie and Full-Term Meconium Packs that contain a recalled Smiths Medi...