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Info Collection on Pediatric Device Development

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Federal Register notice: FDA sends to OMB an information collection reinstatement entitled Yale-Mayo Clinic Centers of Excellence ...

Abbott Recalls FreeStyle Libre 3 Sensors

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Abbott Diabetes Care recalls (Class 1) three lots of its FreeStyle Libre 3 sensors after finding that a small number of them may p...

Medtronic Laryngoscope Recall is Class 1

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FDA says a July Medtronic recall of some McGrath MAC Video Laryngoscopes due to potential battery problems is Class 1.

Glenmark Pays $25 Million in False Claims Case

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The Justice Department says Glenmark Pharmaceuticals, a generic drug manufacturer in Mahwah, NJ, will pay $25 million to resolve c...

Breas Medical Recalls Vivo 45 LS Ventilators

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Breas Medical recalls (Class 1) its Vivo 45 LS ventilators to update the use instructions after internal testing identified the po...

Lilly Reports Positive Data in Weekly Insulin Trials

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Eli Lilly says data from two Phase 3 clinical trials evaluating once-weekly insulin efsitora alfa in adults with Type 2 diabetes s...

FDA Overdue on 2,000 Drug Plant Inspections: AP

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An Associated Press analysis says FDA is overdue on some 2,000 drug company facilities that havent been inspected since before the...

Committee to Consider Iterum Sulopenem NDA

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FDA asks its Antimicrobial Drugs Advisory Committee whether an Iterum NDA for sulopenem etzadroxil/probenecid to treat some uncomp...

Group Seeks Clarity on Use-Related Risk Analyses

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Biosimilars Forum asks FDA for further information and clarification on certain areas of the agencys recent draft guidance entitle...

Drug Nitrosamine Impurity Control Guidance

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FDA publishes a revised guidance on controlling nitrosamine impurities in human drugs.