483
Neurocrine Biosciences IncFDA 483 - Neurocrine Biosciences Inc - July 18, 2024
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An FDA inspection of Neurocrine Biosciences Inc in San Diego, CA, revealed a significant deficiency in their postmarketing adverse drug experience surveillance. The firm failed to develop adequate written procedures for the receipt and evaluation of safety events, specifically regarding Huntington's Disease. This indicates a lack of robust pharmacovigilance processes.
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ID · 7ea6a782-f76f-4f79-b392-74ad4e8fa5b8