www.fdanews.com/articles/96115-company-rsquo-s-legal-victory-against-fda-doesn-rsquo-t-change-policy
Company’s Legal Victory Against FDA Doesn’t Change Policy
July 20, 2007
The FDA’s defeat in U.S. v. Utah Medical Products will not likely alter the agency’s thinking on how it handles enforcement of the quality system regulations, according to Denise Dion, former FDA employee and senior consultant with regulatory/auditing consulting firm EduQest.
The GMP Letter