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FDA drafting preliminary GMP agreement for November meeting with European Union.

This article was originally published in The Tan Sheet

Executive Summary

FDA DRAFTING PRELIMINARY GMP MUTUAL RECOGNITION AGREEMENT WITH EU in preparation for a November meeting with officials of the European Union in Washington, D.C. FDA International Affairs Staff Director Walter Batts explained that "following the July meeting" of FDA and EU officials "we felt that there was enough progress...on some of the key issues that we could begin drafting an agreement." Batts commented on GMP recognition during a PDA/FDA joint conference on regulatory compliance on Sept. 19 in Bethesda, Md.
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