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Remote Site Visits Will Help US FDA Keep Reviews On Track During Remainder Of Pandemic

 
• By Bowman Cox

Video facility tours expected to help clear way for timely drug and biologic approvals while COVID-19 still prevents inspections.

ST.art/Shutterstock.com
at last, guidance from the fda on video plant tours

As the pandemic continues, the US Food and Drug Administration will rely selectively on virtual site visits to help it make timely approval and licensing decisions, though usually not to confirm post-warning letter corrective actions, the agency said 14 April in eagerly awaited guidance on what are generically called virtual inspections, but which it terms “remote interactive evaluations.”

The ability to make decisions based on remote interactive evaluations is an important tool that counterparts like the European Medicines...

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