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Generics Bulletin

Medtech Insight

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

Apr 07 2021

• By Derrick Gingery

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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Additional Topics

United States Coronavirus COVID-19 Generic Drugs Regulation Review Pathway BioPharmaceutical

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