Analysis of FDA's Remote Regulatory Assessments based on Warning Letters
Objective:To introduce the relevant guidlines for remote regulatory assessments issued by FDA and analyze the warning letters issued based on remote regulatory assessments to provide references for the industry.Methods:This paper introduced the remote interactive evaluations guidelines and remote regulatory assessments guidelines issued by FDA,and analyzed the warning letters issued based on remote regulatory assessments from the aspects of defects and the time of issuing warning letters,and put forward reference opinions.Results:Warning letters issued by the FDA based on remote regulatory assessments have unique characteristics in terms of defect terms and timing compared to warning letters issued by inspections.Conclusion:As a new regulatory tool,remote regulatory assessments has its unique advantages and disadvantages,and it also brings new challenges to both regulatory authorities and pharmaceutical manufacturers.
remote regulatory assessmentsremote interactive evaluationswarning lettersgood manufacturing practice for drugsquality management system
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