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Re: bbhuey post# 25322

Friday, 01/16/2009 2:30:54 PM

Friday, January 16, 2009 2:30:54 PM

Post# of 35633
Nice post bbhuey. Here's a snippet from an article that relates to the Japan/U.S. relationship with regard to the FDA and cross-country and international approvals being streamlined:

"Harmonization of guidelines: the FDA is actually leading efforts with its European and Japanese counterparts to harmonize regulatory guidelines for:

* New Drugs (International Conference on Harmonization).
* Medical Devices (Global Harmonization Task Force).
* Veterinary Medications (Veterinary Conference on Harmonization).

Mutual Recognition Agreements: this is where the FDA relies on its European counterparts to inspect European manufacturing plants that are exporting products to the U.S. on behalf of the U.S."

http://66.218.69.11/search/cache?ei=UTF-8&p=japanese+fda&fr=yfp-t-501&u=wistechnology.com/articles/5006/&w=japanese+fda&d=bYCsS0fiSG1U&icp=1&.intl=us

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