US FDA Picks Up The Pace Of Complete Response Letters Over June And July
The year began with an unusually low number of CRLs, but a recent burst of non-approval actions suggests a COVID-19 effect.
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FDA’s interactions with sponsors to support drug development activities are generally timely and effective – but industry still sees room for improvement in assuring ‘best practices’ are followed across all divisions.
Keeping Track: US FDA Has Clinical Questions For Tricida, Gilead And BioMarin; Enspryng And Winlevi Approved
The latest drug approval and decision news from the Pink Sheet’s US FDA Performance Tracker.
Knock-backs for Gilead/Galapagos and BioMarin are a surprise, and could be a sign of the FDA reasserting its 'gold standard' approach to safety and efficacy.