FDA Estimates GSK Seizure Involves $4 Bil. Worth Of Product
This article was originally published in The Pink Sheet Daily
FDA's seizure of GlaxoSmithKline's Paxil CR and Avandamet is the agency's largest in terms of monetary value, involving $4 bil. worth of product, the agency said
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FDA hopes the seizure will serve as a warning to other manufacturers that do not heed guidelines for good manufacturing practices. The decision to bypass other regulatory options was made in consultation with Acting Commissioner Crawford. FDA is currently negotiating a consent decree with GSK.
ClinROs, artificial intelligence-based algorithms will be included in approval pathway. FDA is taking a crash course on new techniques for trial assessment thanks to COVID.
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