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EU mutual recognition proposal "not acceptable," FDA deputy commissioner reiterates.

This article was originally published in The Tan Sheet

Executive Summary

EU MUTUAL RECOGNITION PROPOSAL "NOT ACCEPTABLE" TO FDA as currently envisioned, FDA Deputy Commissioner Mary Pendergast said Oct. 30 at the World Federation of Proprietary Medicine Manufacturers 12th general assembly in Toronto, Ontario. After having been "back and forth" with the European Union, "we are unwilling to accept the situation" in which "we don't inspect in Europe and where we don't even see the inspection report of the person who did inspect," Pendergast said.

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