Reorganization Of US FDA’s Office Of Regulatory Affairs Will Deliver More Preemptive Inspectorate
Executive Summary
Top officials plan to coordinate field operations better by creating agencywide IT systems that could prevent quality failures in programs including drugs, not just respond to them. Siloed systems were blamed for missed opportunity to stem infant formula contamination and prevent subsequent shortages.
You may also be interested in...
US FDA’s Office Of Regulatory Affairs To Focus On Investigations, Inspections And Imports
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.
‘Stop Fighting' US FDA On Inspections As Food Safety Overhaul Brings ‘Big Change’ To Drug Systems – Califf
Commissioner Califf underscores need to keep inspections systems ‘tuned up’ to prevent manufacturers from ‘losing their edge’ on quality.
‘Stop Fighting Us’ On Inspections, US FDA’s Califf Tells Industry; Foods Modernization Will Bring ‘Big Change’ To Drug Quality Systems
Commissioner Califf underscores need to keep inspections systems ‘tuned up’ to prevent manufacturers from ‘losing their edge’ on quality.