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FOOD AND DRUG ADMINISTRATION - page 260 / 263

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DR. HUSSAIN:  Just to add to that, I think when we get reports of therapeutic inequivalence, for example, or side effects, generic versus innovator, our databases right now are not truly optimum to find the signal and to see whether the signal is real or not, and the study that Nakissa is planning to do is to go back and look at select drugs where the endpoint for either the adverse event and so forth are well defined and see whether we can start taking signals of differences between generator and innovator, and based on that maybe, hopefully, construct a better database to be very proactive in looking at these signals, hopefully in real time, later on.

DR. KIBBE:  Anybody else?

(No response.)

DR. KIBBE:  Thank you.

DR. SADRIEH:  Thank you.

DR. KIBBE:  Ajaz, are you going to end?

DR. HUSSAIN:  I'll be very short, and I think everybody's tired, and again I think the two days, plus many of you have attended the third day of the training session, we really appreciate your time and effort, and as

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