‘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.
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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.
To RRA, Or Not To RRA? BD Talks Decision-Making Around FDA Requests For Remote Regulatory Assessments
Three Becton Dickinson facilities have been approached by the US agency to take part in the voluntary virtual assessments; the medtech giant declined one and accepted two. BD’s VP of quality and regulatory compliance explains why.
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.