Multiple Violations in BD Inspection
[ Price : $8.95]
FDA warns Becton Dickinson about multiple violations at its San Diego facility that manufactures the Pyxis Medication Management S...
Clinical Investigation Protocol Deviations
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FDA publishes a draft guidance on defining, identifying, and reporting protocol deviations in clinical investigations.
Updated POLARx Instructions is Class 1 Recall: FDA
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FDA says a Boston Scientific recall updating instructions for two cryoablation balloon catheters is Class 1.
CGMP Violations in Akorn Formulations Review
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FDA warns Akorn Formulations in Hyderabad, Telangana, India, about CGMP violations in its production of over-the-counter drugs for...
Syndax Leukemia Review Extended by FDA
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FDA extends by three months its review of a Syndax Pharmaceuticals NDA for revumenib and its use in treating adult and pediatric p...
