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Re: oldberkeley post# 78092

Monday, 05/18/2009 6:03:49 PM

Monday, May 18, 2009 6:03:49 PM

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MNTA: I seem to remember reading that the FDA itself feels that there is a definite benefit to consumers if the FDA approves more than one ANDA…

I don’t recall any such statement from the FDA. Certainly, there is nothing in the FDA’s statutory charge that directs the agency to act in the manner you suggest. (Perhaps what you heard was a statement from someone in Congress in the context of discussing the renewal of the PDUFA legislation.)


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