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‘One FDA’: US Agency’s New Inspectional Affairs Council Takes Shape

Executive Summary

Top leaders from all commodity centers within the FDA will take part in a new Inspectional Affairs Council that’s being stood up by the agency’s Office of Regulatory Affairs. Acting commissioner Janet Woodcock will also play a role.

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FDA’s New Inspections Council Whipping Up Policy Around Remote Regulatory Assessments

The US FDA says in a report that its Inspectional Affairs Council will develop Remote Regulatory Assessment policies for all commodities the agency oversees. RRAs were launched by the FDA as a way to check on a firm’s regulatory compliance without sending an investigator on-site.

‘Regulatory Agility’ Essential For Inspectional Success In A World With COVID-19: FDA Official

The pandemic caused the US FDA’s Office of Regulatory Affairs to consider ways it can be more nimble in its inspectional activities, including launching an agency-wide council to tackle and solve inspection-related issues, the ORA’s Elizabeth Miller says.

‘We Were A Victim’: How An FDA Remote Regulatory Assessment Took One Device Maker By Surprise

A manufacturer approached by the US FDA to participate in its voluntary Remote Regulatory Assessment program quickly discovered it bit off more than it could chew. It also didn’t help that the investigator running the firm’s RRA seemed to skirt agency protocol around the assessments. RRAs have taken the place of on-site facility inspections during the COVID-19 pandemic.

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