Perspectives on the U.S. FDA Bioresearch Monitoring Program.
An overview is presented of the U.S. FDA Bioresearch Monitoring Program from the field perspective. The presentation includes current insight as to how FDA conducts field audits in various program areas and observations regarding shared responsibilities for ensuring both quality data and patient safety during the preclinical and clinical investigation processes.
United States Food and Drug Administration, New Orleans Investigations Branch, Louisiana 70122, USA.
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D002986:Clinical Trials as Topic / Q000592:standards; D018795:Device Approval; D017277:Drug Approval; D005161:Facility Regulation and Control / Q000592:standards*; D005568:Forms and Records Control / Q000592:standards; D008331:Management Information Systems / Q000592:standards; D011786:Quality Control; D012106:Research / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*