Oversight Tools Piloted During COVID-19 Pandemic Are Here to Stay: FDA Issues Draft Guidance on Remote Regulatory Assessments

Lexology August 11, 2022
Sidley Austin LLP

The COVID-19 pandemic resulted in an unprecedented disruption to the U.S. Food and Drug Administration (FDA) inspection program. With the vast majority of its inspectional activities suspended due to the pandemic, FDA was forced to pilot new and unfamiliar inspectional initiatives, including remote interactive evaluations, increased use of records requests under 21 USC 374(a)(4) — commonly known as 704 requests — and increased reliance on other health authorities’ inspections under the Mutual Reliance Agreement.

On July 22, 2022 the FDA released new draft guidance, “Conducting Remote Regulatory Assessments Questions and Answers” (the RRA Guidance), describing the agency’s plan to continue to use these alternative inspectional initiatives beyond the COVID-19 pandemic. FDA’s continued use of these tools, broadly defined as “remote...

Today's Sponsors

Today's Sponsor