MRA Expense Raises Doubts At FDA, Fuels Debate On Voluntary Status
This article was originally published in The Gray Sheet
Executive Summary
Certification of European Union conformity assessment bodies under the U.S./EU mutual recognition agreement could require FDA Office of Compliance expenditures of $18 mil., according to rough estimates provided by OC official Kim Trautman at the Food and Drug Law Institute's 42nd Annual Educational Conference Dec. 17.