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.

Navigating to Leverkusen (photo illustration/shutterstock)
FDA inspectors took a trip to Bayer’s facility in Leverkusen, Germany for a pre-approval inspection during the pandemic. • Source: photo illustration/Shutterstock

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