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GMP Inspection Results Can No Longer Stay Within Borders, Says U.S. FDA

This article was originally published in PharmAsia News

Executive Summary

Results from manufacturing facility inspections conducted in one country will easily be shared with regulators in another in the near term, says Larry Kessler, U.S. FDA officer and chair of the Global Harmonization Task Force

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Global Drug Regulators And Manufacturers Grapple With How To Ensure Global Quality Standards (Part 2 Of 2)

[Editor's note: This is part two of a two-part feature on ensuring drug quality, as discussed at the Fifth IFPMA Asian Regulatory Conference in Kuala Lumpur. Part one appeared in PharmAsia News, March 17, 2008.]

Regulatory Harmonization Takes Center Stage At IFPMA Asia Event

KUALA LUMPUR, Malaysia - Industry and regulators in Asia are mapping out strategies for regulatory harmonization, mostly borrowed from the U.S. and European Union experiences, in an effort to help the rapidly growing Asian pharmaceutical markets

U.S. FDA Move “Beyond Our Borders” Begins With China

Congressional concerns over inspection oversight in the midst of a heparin safety scare have not dampened FDA's efforts to highlight its new overseas initiative, "FDA Beyond Our Borders.

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