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FOOD AND DRUG ADMINISTRATION - page 20 / 263

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coordinated through a steering committee which consists of members from our Office of Regulatory Affairs, our Center for Biologics Evaluation and Research, our Center for Veterinary Medicine, from CDER, the Center for Drug Evaluation and Research, from our Office of the Commissioner with input both from CDRH, which is our Center for Devices and Radiological Health, and CFSAN, which is our Center for Food Safety and Applied Nutrition.

We really, when we started this initiative back in August, envisioned that it would take two years to really -- and I won't say finalize the initiative but to put the major part of the work into the initiative.  Obviously it's something that will go on for a number of years out to really incorporate all those aspects of the initiative that are really important to ensure that we focus on the right things as far as quality is concerned.

We did provide our first six-month report in February, on February 20th, and we have done a lot of work in the six months within the agency, looking at how to make a number of changes, and I'll talk about that more.

I just wanted to quote Dr. McClellan here because I think his quotes are very significant when we

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