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Remote Site Visits Will Help US FDA Keep Reviews On Track As Pandemic Constraints Continue

 
• By Bowman Cox

Guidance discusses what are generically called virtual inspections, but which the agency terms “remote interactive evaluations.” As site inspections remain constrained by the pandemic, remote interactive evaluations “should help FDA operate within normal timeframes,” the document says.

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FDA PUBLISHES GUIDANCE ON VIDEO PLANT TOURS.

The US Food and Drug Administration will rely selectively on virtual site visits as the coronavirus pandemic continues to help it make timely approval and licensing decisions, though usually not to confirm post-warning letter corrective actions, the agency says in an eagerly awaited guidance.

The guidance published on 14 April discusses what are generically called virtual inspections, but which the agency terms “remote...

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More from Policy & Regulation

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