ANDA Sponsors Could Lose Exclusivity Because COVID-19 Prevented An Inspection … Or Not

 
• By Derrick Gingery

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.

Pill with security shield
Guidance on generic development during the pandemic does not allow use of non-US approved reference products. • Source: Shutterstock

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