Inspection Outcomes Could Get Boost From ORA Reorganization, Says Regulatory Expert

The FDA’s proposed transformation of the Office of Regulatory Affairs (ORA) will not only see the office transfer all compliance functions to product centers but could also lead to more efficient inspection planning and execution as well as more effective and timelier regulatory compliance actions.

That’s according to Donald Ashley, executive vice president of regulatory compliance at Greenleaf Health, speaking Wednesday at the 18th annual FDA Inspections vSummit sponsored by FDAnews, a WCG company.

Ashley noted that ORA’s reorganization will allow the office to focus on a much narrower mission of just conducting inspections, investigations and imports, enabling the center to become far more efficient at these core tasks in the process. 

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