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FDA Reflection This Thanksgiving: Alliance

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As families sit down for Thanksgiving meals, the Alliance for a Stronger FDA says consideration should be given to FDA staff for t...

Adverse Event Reports Vary in Completeness

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University of Tokyo researchers say that adverse events reports submitted to FDA vary in completeness depending on the occupation ...

Teva, Others Try to Resolve Price-Fixing Probe

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Bloomberg News says the federal government and several generic drug companies have been in discussions to resolve an ongoing antit...

Invokana Could Change DKD Treatment: Spherix

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Spherix Global Insights says FDA approval of a new indication for Janssens Type 2 diabetes drug Invokana to slow the progression o...

Vasisht Named Associate Commissioner for Womens Health

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FDA names Kaveeta Visisht to be associate commissioner for womens health.

CGMP Violations at Lohxa LLC

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FDA warns Lohxa LLC about CGMP violations in its production of finished pharmaceuticals.

Device-Related Infections Likely Antibiotic-Resistant: Study

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A Center for Disease Control and Prevention report says that healthcare-associated infections resulting from medical devices are m...

CymaBay Stops Seladelpar Studies Over Safety Concerns

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CymaBay Therapeutics terminates a Phase 2b study of seladelpar in subjects with non-alcoholic steatohepatitis and its recently ini...

FDA Reopens Tobacco Product Comment Period

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Federal Register notice: FDA reopens for 20 days the comment period on a 9/25 proposed rule on premarket tobacco product applicati...

Intercept NDA for NASH Drug Accepted

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FDA accepts for priority review an Intercept Pharmaceuticals NDA for obeticholic acid seeking accelerated approval for treating fi...