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US FDA Explains How It Is Embracing Remote Assessments Post-Pandemic

 
• By Bowman Cox

Agency provides new details on plans for various remote methods of assessing manufacturing establishments that became popular when investigators were prevented by COVID-19 pandemic travel restrictions from visiting sites in person.

Virtual inspection
when the fda will show up remotely • Source: Shutterstock

The US Food and Drug Administration on 22 July said it will keep doing remote regulatory assessments of drug manufacturing plants, clinical investigator sites and other FDA-regulated establishments, even when the COVID-19 pandemic no longer prevents travel for site inspections – and provided some insight into why.

The experience the agency developed with various types of remote assessments during the public health emergency “has identified significant benefits of using RRAs to FDA, regulated industry and the public,”...

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