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Mutual recognition of GMP inspections

This article was originally published in The Gray Sheet

Executive Summary

FDA's "overall strategy" for achieving mutual recognition of good manufacturing practices inspections is to continue with existing agreements with other governments, "learn from that experience...and apply those lessons toward refining and tailoring the key considerations and factors that go into" the agency's approach to such arrangements, FDA says in a plan released May 21 on its website (www.fda.gov). Publication of the plan fulfills Sec. 410(c)(4) of the FDA Modernization Act, which mandates that FDA publish within six months of the law's enactment a plan that "establishes a framework for achieving" agreements for the recognition of GMP inspections...

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