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DewDiligence

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DewDiligence

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Re: DewDiligence post# 35798

Friday, 10/20/2006 4:24:49 PM

Friday, October 20, 2006 4:24:49 PM

Post# of 257302
CDER slides on the new initiative for generic drugs:

http://www.fda.gov/cder/present/galson_OGD2006.pdf

Note the mention of citizen petitions in slide #4. An ANDA that has an outstanding citizen petition is not eligible for priority review under the new rules, which is a very wide loophole.

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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