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Podcast: CDER’s Woodcock On COVID-19 – Missed User Fees Unlikely, But Some Work Will Be ‘Set Aside’

 
• By Kate Rawson

In a podcast interview, Janet Woodcock talks about review deadlines, prioritizing pre-approval inspections, and how advisory committees could be held in an era of social distancing.

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Most US Food & Drug Administration review teams should be able to meet user fee deadlines in the near term amid changing work patterns prompted by the COVID-19 outbreak, although review divisions that are central to addressing the crisis – including antiviral, critical care and pulmonary – may need to prioritize their workloads, Center for Drug Evaluation & Research Director Janet Woodcock told the Pink Sheet.

“So far, it seems like people are being able to get their work done,” Woodcock said in a podcast interview

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