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.
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Responses to FDA draft guidance suggest more promptness while also more elaborate processes for agency decision making based on remote methods. Questions include what’s voluntary, what’s mandatory, what can be decided remotely, and how to remotely move on from warning letters.
CHPA members’ feedback on RRAs indicate that “time and resources saved by FDA do not translate to time saved by the manufacturer.” CRN suggests FDA “clearly identify the purpose of the RRA in its initial request and limit requested documents to only those directly related to the purpose of the RRA.”
“We're looking to expand the use of this tool make it a more routine part of our operations going forward,” says Michael Dutcher, deputy director, ORA Office of Human and Animal Food Operations. “In general, the response from industry has been pretty positive” about RRAs.