September 28, 2021

Volume XI, Number 271

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September 27, 2021

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FDA Releases Forward-Looking Report on Inspections

  • On May 5, FDA released a report titled “Resiliency Roadmap for FDA Inspectional Oversight,” explaining how FDA adjusted its inspection program during the COVID-19 pandemic and providing details on its priorities moving forward. In March 2020, FDA responded to COVID-19 by postponing all domestic and foreign routine facility inspections, only resuming prioritized domestic inspections in July 2020.

  • The report explains that as FDA works to make up for lost time during the pandemic, it plans to continue to prioritize routine surveillance inspections for high-risk facilities and conduct inspections over a longer period of time.  As a result, certain lower-risk facilities may have an increased amount of time between inspections. The report proposes several different scenarios for a return to normal inspection schedules, considering best-case and worst-case scenarios.

  • The report also mentions FDA plans to begin a multi-year modernization plan for data enterprise platforms and cross-program interoperability infrastructure to better support innovation related to its regulatory oversight role, including remote approaches. FDA will review its approach to inspections with updated assessment programs and establish an agency-wide FDA Inspectional Affairs Council to plan and coordinate inspectional activities.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 127
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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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