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CGMP Violations at Lohxa LLC

[ Price : $8.95]

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...

Device Sterilization Master File Pilot

[ Price : $8.95]

Federal Register notice: CDRH announces an Ethylene Oxide Sterilization Master File Pilot Program that will allow sterilization pr...

Tobacco Product Modifications Compliance Policy

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Federal Register notice: FDA makes available a guidance entitled Compliance Policy for Limited Modifications to Certain Marketed T...

Tusker Medical Ear Infection Tubes Approved

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FDA approves a Tusker Medical PMA for the Tubes Under Local Anesthesia System for delivery of tympanostomy tubes (ear tubes) that ...

Bipartisan Call to Update 21st Century Cures Act

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Reps. Upton and DeGette start a process to improve the 21st Century Cures Act.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes EPH Technologies and Lohxa.

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 ...