Increased use of virtual tools, optimized inspectional activ

Increased use of virtual tools, optimized inspectional activities, & enhanced supply chain oversight | Hogan Lovells


The future of inspections under FDA’s COVID-19 PREPP initiative
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On January 13, FDA published a summary report on the agency’s Pandemic Recovery and Preparedness Plan (PREPP) initiative, which was launched internally in April 2020 and announced publicly in August 2020. According to the summary report, the PREPP initiative is aimed at strengthening FDA’s ongoing COVID-19 response and building the agency’s resilience to respond to future emergencies, including by identifying several “broad cross-cutting ‘Action Areas’ that reflect ongoing and potential prospective actions.” Notably, these action areas include “continu[ing] to evolve and optimize inspectional operations, building on the COVID-19 experience as a catalyst” and “strengthen[ing] supply chain surveillance for regulated products,” suggesting that several of FDA’s COVID-related inspection pilot projects will continue into the future.

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