FDA Updates Q&A Guidance on Inspections During COVID-19 Pandemic

The US Food and Drug Administration (FDA) has updated its question-and-answer guidance regarding facility inspections during the COVID-19 pandemic to clarify regulatory actions to take place when onsite inspections are not feasible.

The revisions update the agency’s guidance, Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers, issued in August 2020, and follow’s a separate report on the use of alternative tools and approaches where inspections were or are not currently feasible, including remote interactive evaluations.

The FDA issued the updated guidance to provide answers to frequently asked questions about regulatory and policy issues related to inspections, pending drug applications, and changes in manufacturing facilities for approved pharmaceutical products.

The updated question-and-answer guidance, issued on May 11, 2021, may be found here.

Source: US Food and Drug Administration

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