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Velocity Marketed Adulterated Eye Drops: FDA

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

CGMP Violations at Guangzhou Baiyunshan

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FDA warns Chinas Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. about CGMP violations in its production of finished drug...

Enhancing Diversity in Pediatric Drug Development Workshop

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

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...

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...