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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

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