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

Agency provides additional details on plans for various remote methods of assessing Rx and OTC drug manufacturing facilities that became popular when investigators were prevented by COVID-19 travel restrictions from visiting sites in person.

Virtual inspection
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The US Food and Drug Administration will continue remote regulatory assessments of drug manufacturing plants, clinical investigator sites and other regulated facilities after the COVID-19 pandemic no longer prevents travel for site inspections, the agency says in a draft guidance.

In a notice scheduled for publication in the 25 July Federal Register, the agency also offers some insight into why it will continue RRAs. The experience it developed with various...

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