FDA Inspections Ombudsman Could Help Foreign Manufacturers
Executive Summary
New ORA position intended to help get questions answered, but already being used to smooth inspection issues.
You may also be interested in...
US FDA’s New Compliance Chief Donald Ashley Brings International Law Enforcement Experience
Ashley's many years in the Department of Justice’s Office of International Affairs should be a plus for agency's globalization efforts.
Despite Globalization, Three Quarters of Serious Inspection Issues FDA Found Were in US
Interactive map, charts provide details on our analysis of FDA 2009-2014 inspection results data showing that even as the agency responded to the threat of poor drug quality abroad, it was more successful at finding serious quality issues during its much more numerous domestic inspections.
GDUFA II: Inspection Information Takes Center Stage
Sponsors say transparency is important as generic drug user fee negotiations move to inspection policy.