FDA is issuing this draft guidance to inform industry about the agency’s continued use of remote evaluations as an approach for evaluating drug facilities, as appropriate. This guidance articulates the specific conditions that both the facility and FDA should meet when preparing for, conducting and concluding a remote interactive evaluation at facilities where drugs are manufactured, processed, packed, compounded, or held, and at drug facilities covered under FDA’s bioresearch monitoring (BIMO) program.
Download the full guidance document here.