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European inspections would be public under FoI in MRA agreement-in-principle.

This article was originally published in The Tan Sheet

Executive Summary

FOREIGN INSPECTION REPORTS WOULD BE AVAILABLE UNDER FREEDOM OF INFORMATION ACT to the extent required by domestic law in both the U.S. and the European Union under the terms of a Good Manufacturing Practice mutual recognition agreement-in-principle. The agreement would allow FDA to use uniform disclosure laws for inspection reports regardless of whether an inspection was conducted by FDA in the U.S. or by a European inspector under the MRA. FDA releases redacted inspection reports with confidential commercial information removed.
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