ANDA Sponsors Could Lose Exclusivity Because COVID-19 Prevented An Inspection … Or Not
US FDA will determine on a case-by-case basis whether its inability to inspect a facility because of the pandemic could result in 180-day exclusivity forfeiture for first generic filers.
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Fewer inspections but more warning letters, import alerts and drug-shortage discretions were seen as office sought to ameliorate COVID-19 impacts.
Agency's Janet Woodcock and Judy McMeekin say the FDA is looking at options like livestream plant videos while preparing to address backlog after inspections can resume.
As agency implements testing program for its staff, sponsors are drawing up protocols to ensure inspector safety and forwarding them to FDA, but still can’t trigger an inspection.