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FDA Evaluating Higher Death Rate with Dual Antiplatelet Therapy

[ Price : $8.95]

FDA says it is evaluating preliminary data from a clinical trial showing an increased overall risk of death for patients on dual a...

Genzyme Gains Approval for Lemtrada for MS

[ Price : $8.95]

FDA approves a Genzyme NDA for Lemtrada (alemtuzumab) for treating patients with relapsing forms of multiple sclerosis.

Solgar Recalls Dietary Supplement Due to Fungus

[ Price : $8.95]

Solgar, Inc. recalls its ABC Dophilus Powder after testing by the Centers for Disease Control revealed the presence of Rhizopus or...

FDA Seeking to Double Inspectional Presence In China

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FDA says an ongoing hold on China-issued visas is expected to be lifted in the coming weeks which will double its inspectional pre...

84% Say CDRH Delivering Good Customer Service

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An ongoing CDRH customer survey finds that 84% of respondents are satisfied with the Centers customer service.

Kremers Urban Generic Concerta Downgraded Due to BE Concerns

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FDA tells Kremers Urban Pharmaceuticals that it will need to conduct an additional bioequivalence study based on a recently issued...

Industry Wants More Guidance on Biomarker Use in Trials

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Pharmaceutical Research and Manufacturers of America says FDA should develop a guidance document on conducting trials in biomarker...

Comments Sought on Export Certificate Requirements

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Federal Register Notice: FDA invites comments on information collection requirements for firms intending to export FDA-regulated p...

Janssens Invega Sustenna Approved for Schizoaffective Disorder

[ Price : $8.95]

FDA approves a Janssen Pharmaceuticals supplemental NDA for the once-monthly atypical antipsychotic Invega Sustenna (paliperidone ...

FDA Clears SQI Diagnostics Celiac Assay

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FDA clears a SQI Diagnostics 510(k) to market its proprietary Celiac Panel, an Ig plex Celiac DGP in vitro diagnostic test.