KEY POINTS

Don’t call us, we’ll call you. Facilities must be prepared to host remote interactive evaluations if the FDA requests them, and that includes being ready to interact with the agency’s technology platforms and having a strong wi-fi signal throughout the facility, even in those trouble spots they might wish investigators would pass by.

A commitment to new products. The FDA will use remote evaluations to help meet user fee commitments for regulatory reviews.

Data integrity caveat. You may not get the call if your plant has demonstrated poor data integrity.

Post-warning letter remediation. Unfortunately, the remote evaluations may not help much when it comes to checking whether companies have fixed problems raised in warning letters – that will usually require site visits.

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

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