MRA Expense Raises Doubts At FDA, Fuels Debate On Voluntary Status
This article was originally published in The Gray Sheet
Executive SummaryCertification 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.
You may also be interested in...
A surge in Chinese applications for clinical trials for coronavirus treatments, and a fall in patient numbers, are complicating recruitment efforts for the most promising drugs, prompting official moves to tighten study rules.