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Man Sentenced for Misbranded Drugs

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The Justice Department says a Virginia man who pleaded guilty to distributing misbranded drugs via the Internet has been sentenced...

Reclassify Some Oncology Panels: Petition

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Foundation Medicine petitions FDA to reclassify all next-generation sequencing oncology panel devices used for somatic or germline...

Pentax Duodenoscope Cleared for New Reprocessing

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FDA clears a Pentax Medical 510(k) to acknowledge its DEC (Disposable Elevator Cap) Duodenoscopes compatibility with Advanced Ster...

Petition Seeks Govt Action to Allow Generic Semaglutide

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Public Citizen petitions HHS to use its authority under 28 USC. 1498 to permit generic competitors to manufacture Novo Nordisks s...

Drug Safety Committee Renewed

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FDA renews the Drug Safety and Risk Management Advisory Committee for an additional two years.

Labcorp Gets De Novo for Tumor Assay

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FDA grants Labcorp a de novo marketing authorization for its PGDx elio plasma focus Dx kitted assay.

Exactech Joint Replacement Device Recall Updated

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FDA updates an Exactech recall involving its joint replacement devices manufactured between 2004 and 2021.

Rare Disease Status for Hyperoxaluria Drug: META

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FDA grants META Pharmaceuticals a rare pediatric disease designation for META-001-PH, an investigational drug for treating primary...

Another Study Needed for Iomab-B BLA: FDA

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FDA asks Actinium Pharmaceuticals for another Phase 3 study to support a BLA submission for Iomab-B in patients with active relaps...

Anesthetic/Analgesic Drugs Panel Renewed

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Federal Register notice: FDA announces the renewal of the Anesthetic and Analgesic Drug Products Advisory Committee for an additio...