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we don't always do, either from the review or the GMP aspect, and recently, we have reorganized, at least CDER's Office of Compliance, to better focus on how we can improve our risk management.

The pharmaceutical inspectorate.  Basically what we want to do in the agency, for at least pharmaceuticals, is to set up a specific cadre of inspectors in the field who can focus and have better knowledge on drugs so that when they go out, they have a better understanding of not only the manufacturing processes but of the products themselves.

We're hoping through this to enhance the agency's expertise in pharmaceutical technologies, to ensure state-of-the-art pharmaceutical science.  What we'll do is, although we do have staff in our field operations now who will move into this cadre, we're looking to enhance that staff with additional staff and to continue to increase their expertise through better training, maybe even better involvement with the industry, training through the industry facilities as well, and also establish a closer working relationship between the field and the centers.

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