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Replies to #78092 on Biotech Values
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DewDiligence

05/18/09 6:03 PM

#78118 RE: oldberkeley #78092

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.)