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September 17, 2008

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FDA to hold public meeting on harmonization of medicinal product processes

September 16, 2008
World Trade\Interactive

The Food and Drug Administration will hold a public meeting Oct. 21 in Rockville, Md., to prepare for the Nov. 10-13 meetings of the International Conference on Harmonization’s Steering Committee and Expert Working Groups. According to the FDA, the ICH is a joint regulatory/industry project to improve, through harmonization, the efficiency of the process for developing and registering new medicinal products in Europe, Japan and the U.S. without compromising the regulatory obligations of safety and effectiveness. One of the goals of harmonization is to identify and then reduce differences in technical requirements for medical product development among regulatory agencies.

 

 

 

 

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