Bayer’s Lampit Has Unique Status: US FDA’s Most ‘Critical’ Approval In 2020
Among the 53 new molecular entities cleared by FDA in 2020, Bayer’s Chagas disease therapy Lampit has a unique distinction: the approval required an in-person inspection that FDA actually conducted amid the COVID-related shutdown of routine pre-approval site visits.
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Influence of expedited review pathways and regulatory incentives is on display in 2020’s novel approvals, which have a composition reassuringly consistent with recent years.
The latest US FDA approvals and actions from the Pink Sheet’s US FDA Performance Tracker.
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