‘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.
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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.
US FDA Food Safety Overhaul Will Have Ripple Effects For Drug Inspections
A restructuring of FDA’s food safety operations includes changes to the agency-wide office that handles all inspections, including those of drug manufacturers. It’s another shift in the delicate balancing of centralized management of ORA with the specific needs and priorities of the different centers.
US Supplement Industry Left Waiting For Changes In FDA ‘Unified’ Food Programs Reorganization
“Something needed to be done” to improve FDA’s regulation of human foods supply, says Commissioner Califf says. “Dietary supplements is a whole different kettle of fish that we can discuss at a later time.”