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initiative moves along, too, we'll go out for other contracts to help us in the agency in gaining more knowledge.

International.  When the initiative first started back in August of last year, Dr. Crawford and then later Dr. McClellan, when he came on board, wanted to be certain that we include the scope of international in our thinking as far as this was concerned.  He felt like that there's a lot of efforts that take place, especially for industry.  There's a lot of confusion sometimes between what we here in FDA do and what's done internationally, and he felt like this was an important part of what we needed to look at as we instituted more quality systems internally and as we looked at how we were going to ensure quality in the future.

We felt like it was important to have harmonized approaches as we looked at drug product quality, and we're doing some of that with working with ICH specifically in the realm of technological advances.  In Brussels this summer, we'll begin talking about a lot of these areas at ICH.  We're looking at other forums for harmonization, and also we want to be able to benchmark

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