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Federal Register

Enhancing Diversity in Pediatric Drug Development Workshop

Federal Register notice: FDA announces a 9/6 public workshop entitled Enhancing Diversity in Therapeutics Development for Pediatric Patients to discus...

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Human Drugs

Man Sentenced for Misbranded Drugs

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

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Medical Devices

Reclassify Some Oncology Panels: Petition

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

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Human Drugs

Velocity Marketed Adulterated Eye Drops: FDA

FDA warns Melville, NY-based Velocity Pharma that it has received and distributed adulterated eye drop products produced for it by a contract manufact...

Medical Devices

Pentax Duodenoscope Cleared for New Reprocessing

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

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Human Drugs

Petition Seeks Govt Action to Allow Generic Semaglutide

Public Citizen petitions HHS to use its authority under 28 USC. 1498 to permit generic competitors to manufacture Novo Nordisks semaglutide, the acti...

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Human Drugs

Drug Safety Committee Renewed

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

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Human Drugs

Labcorp Gets De Novo for Tumor Assay

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

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Medical Devices

Exactech Joint Replacement Device Recall Updated

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

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Human Drugs

Rare Disease Status for Hyperoxaluria Drug: META

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