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Post# of 108195
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Re: yessum post# 87

Wednesday, 05/06/2009 9:57:34 PM

Wednesday, May 06, 2009 9:57:34 PM

Post# of 108195
By statute, the FDA must review and respond to an Orphan Drug application within sixty (60) days.

The approval time for orphan products is often considerably shorter than the approval time for other drugs. This reduced approval time is due to expedited review or accelerated approval because the drugs treat serious or life-threatening diseases.

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