US FDA Regulatory Affairs Reorg To Include Inspectors Trained In Real-World Evidence, Califf Says
The US FDA Commissioner acknowledged that the inspectorate has not been prepared for RWE, but as part of the revamp, a dedicated team will encourage its use “when it’s appropriate.”
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US FDA’s New Regulatory Affairs Head Should Be ‘Highly Technically Competent’ But ‘Splendid On The Human Side,’ Califf Says
Agency has seen ‘a good slate of applicants’ for the post of associate commissioner for regulatory affairs, who will oversee a revamped field organization focused on inspections, investigations and imports. New update to the reorg plans calls for medical product and specialty labs to be moved out of the Office of Regulatory Affairs and relocated to the Office of the Chief Scientist.
ORA to shed more responsibilities as the FDA focuses the likely-to-be renamed field organization more on inspections while revamping the agency's Human Food Program.
Without sponsors willing to work with them and in the absence of legislation giving FDA authority over lab-developed tests, the agency has launched internal programs to both gain more oversight – and spur innovation.