USA – Remote regulatory assessments: Pharma, device groups want more details on FDA guidance

Trade groups representing the pharmaceutical and medical device industries, while largely supporting the use of remote regulatory assessments (RRAs) as outlined in the US Food and Drug Administration’s (FDA)’s recent draft guidance, questioned how these assessments would work in practice, including how they would be coordinated with onsite inspections, whether they can be leveraged by foreign regulators and how FDA plans to ensure the privacy of companies and personnel that are subject to live-streaming.

While FDA has been conducting remote assessments since the start of the pandemic, its guidance, once finalized, would formalize its plan to use these assessments to supplement onsite inspections as it eases out of the pandemic response mode. The draft guidance was released in May. (RELATED: FDA describes plans to expand remote regulatory assessments, Regulatory Focus, 22 July 2022)

The agency received 26 comments on the guidance, with responses from a wide range of medical device and pharmaceutical trade groups, as well as consumer and food industry groups…