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FDA Inspection Alternatives During the COVID-19 Pandemic: Requesting, Preparing for, and Responding to an FDA Virtual Inspection

June 15, 2020
Coronavirus: Life Sciences and Healthcare Regulatory Webinar
By Howard Sklamberg Mary D. Oates, Ph.D., Ricki A Chase, M.S.

Due to COVID-19 travel and safety concerns, the Food and Drug Administration has suspended most of its foreign and domestic inspections. In order to avoid delays in evaluating applications to market drugs, devices, and biologics because of the lack of an in-person inspection, FDA has recognized the need to rely on alternatives, such as virtual inspections and obtaining documents in lieu of inspection. For companies who seek approval for new products or who are preparing for an inspection to resolve an FDA warning letter, it is important to know what inspection alternatives are permitted.

During this webinar, co-hosted with Lachman Consultant Services, we discuss virtual FDA inspections, including how medical products companies should engage with FDA, prepare for virtual inspections, and respond to any compliance issues that may arise.

To help our clients navigate the coronavirus (COVID-19) crisis, Arnold & Porter has established a Coronavirus Task Force covering a wide range of issues and challenges. Subscribe to our "Coronavirus (COVID-19)" mailing list to receive our latest client Advisories and register for upcoming webinars.

Meet the Speakers

Mary D. Oates, Ph.D.
Lachman Consultant Services
Ricki A Chase, M.S.
Lachman Consultant Services
Howard Sklamberg
Partner
Arnold & Porter
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