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FDA Avoided Half Of ANDA Pre-Approval Inspections During COVID By Using Alternative Tools

 
• By Derrick Gingery

Records reviews are common now in lieu of an in-person inspection for US generic applications, but more virtual facility checks could be coming soon.

Files under review
Previous four fiscal quarters showed a more than 50% reduction in the PAI inspections that were needed. • Source: Alamy

Alternative tools allowed the US Food and Drug Administration to avoid a substantial number of prior approval inspections during the coronavirus pandemic, potentially helping cement their use in the post-COVID-19 world.

Sau Lee, deputy director of science in the FDA Center for Drug Evaluation and Research’s Office of Pharmaceutical Quality, said on 28 April during the FDA Generic Drugs Forum that...

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