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DewDiligence

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DewDiligence

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Re: Biowatch post# 52766

Thursday, 09/27/2007 9:04:35 PM

Thursday, September 27, 2007 9:04:35 PM

Post# of 257302
The new PDUFA bill contains provisions re citizen petitions.

http://www.fdalegislativewatch.com/2007/09/fda-bill-passes.html

>>
Changes to the citizen petition provisions for protesting generic drug applications state that FDA may not delay generic drug approval because of a petition, unless necessary to protect public health. A decision on a petition must be made within 180 days of its filing, and a filer must wait 180 days after filing before going to court to challenge a generic approval.
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