Baxter
This article was originally published in The Gray Sheet
Executive Summary
FDA needs to ensure a level playing field in EU member countries with respect to inspection activity, length of inspections, number of auditors and frequency of inspections under the June 1997 brokered U.S./EU mutual recognition agreement. Baxter also requests in May 8 comments to the agency that EU audit reports be publicly accessible via a system identical to the Freedom of Information Act, and that the MRA should include biologics and plasma derivatives