FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations

May 5, 2021

line drawing of a roadToday, the U.S. Food and Drug Administration issued a new report titled, “Resiliency Roadmap for FDA Inspectional Oversight,” outlining the agency’s inspectional activities during the COVID-19 pandemic and its detailed plan to move toward a more consistent state of operations, including the FDA’s priorities related to this work going forward.

The agency will also soon begin a multi-year modernization effort to further transform their data enterprise platforms and cross-program interoperability infrastructure to better support innovation related to its regulatory oversight role, including remote approaches. This modernization effort will include a review of inspectional approaches using next-generation assessment technologies and improvements. The FDA is also establishing an agency-wide FDA Inspectional Affairs Council that will plan and coordinate inspectional activities. The agency intends to share more information on these efforts as this work progresses. The FDA will continue to leverage and maximize every available tool and resource to meet its inspectional responsibilities, while achieving optimal public health outcomes.

Read the full statement online.