GAO report on GMP harmonization
This article was originally published in The Gray Sheet
Executive Summary
FDA's device center provides the General Accounting Office with comments regarding a GAO draft report on international harmonization of good manufacturing practices. The report, which compares FDA GMPs with those in the European Community, Japan and Canada, was requested by Rep. Henry Waxman (D-Calif.) ("The Gray Sheet" July 27, In Brief). A final copy of the report will be released after GAO considers FDA's comments.