FDA Issues Guidance on Use of Remote Drug Facility Assessments

The FDA released a draft guidance Thursday on its expanded use of remote tools since the Covid-19 pandemic to assess manufacturing facilities during a drug review process when in-person inspections aren’t feasible.

The Food and Drug Administration said it will use a “risk-based approach” to determine how it will continue to use alternative methods such as remotely requesting records from manufacturers; performing remote interactive evaluations of facilities such as livestreaming video of operations, teleconferences, and screen sharing; and requesting inspection reports and other information from foreign regulatory partners in lieu of regular inspections in certain instances.

The draft guidance outlines ...