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FDA Now Worried About Metformin Containing Carcinogen

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FDA says it has added diabetes drug metformin to its watch list of drugs with potential safety concerns after a cancer-causing imp...

FDA Clears Gynesonics Fibroid Ablation Device

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FDA clears a Gynesonics 510(k) to market its next generation Sonata System 2.1 for Transcervical Fibroid Ablation.

Senators Quiz FDA on Hand Sanitizers

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U.S. senators Joni Ernst (R-IA) and Chuck Grassley (R-IA) write to FDA asking for clarification on its temporary policy for manufa...

Recommendations for Residual Solvents

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Federal Register notice: FDA makes available draft recommendations for new permitted daily exposures (PDEs) for the residual solve...

Russian Ventilators Entered U.S. Without FDA Oversight: Reuters

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Reuters reports that a shipment of Russian ventilators that have been implicated in fatal hospital fires in that country were admi...

4DMedical Lung Imaging Tool Cleared

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FDA clears a 4DMedical 510(k) for its XV Technology, a patented four-dimensional lung imaging process that is intended to rapidly ...

FDA N95 Respirator Reprocessing Reminder

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FDA reminds healthcare facility reprocessing staff to use the correct ASP Sterrad sterilization system decontamination cycle with ...

Amivas NDA for Artesunate Approved for Malaria

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FDA approves an Amivas NDA for artesunate for injection 110 mg, powder and solvent for solution, indicated for the initial treatme...

FDA Approves VESIcare Pediatric Bladder Indication

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FDA approves a new indication for Astellas VESIcare in an oral suspension to treat a type of bladder dysfunction in pediatric pati...

FDA Denies Petition to Probe Edwards Lifesciences Marketing

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FDA denies a petition asking it to investigate and take enforcement action against Edwards Lifesciences for marketing an annulopla...