‘One FDA’: US Agency’s New Inspectional Affairs Council Takes Shape
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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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.
US FDA device center director Jeff Shuren on 6 May shed a tiny bit of light on the agency’s newly announced – but not defined – Inspectional Affairs Council.
A 5 May report from the US FDA says that even under the most favorable COVID-19 conditions the agency’s inspections of makers of medical and tobacco products will likely be cut in half this fiscal year. The FDA also announced it will launch an agency-wide Inspectional Affairs Council to “plan and coordinate inspectional activities.”