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cGMPs for the 21st Century, we actually look at it as the drug product quality initiative because, as I was mentioning yesterday, this covers far more than just the cGMPs.  It covers the review aspect of quality as well.  So it's basically a continuum from the day the products come in and how we look at the quality to come in for review for marketing to the day they basically are no longer on the market.  So it is a continuum and we like to think of it in those terms.

I'm going to talk about the initiative.  I'm going to run quickly through the various aspects of the initiative just so you'll have an idea of what it entails, and then Ajaz is going to sort of make the connection between many of the things we're going to be doing here at the advisory committee as well as on the various subcommittees.

First of all, just let me talk briefly about the goals of the initiative.  It's basically conceived of to incorporate concepts of risk management and quality systems in what we do in our daily activities in the agency.

It also includes the latest scientific

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