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Re: sts66 post# 23828

Monday, 01/13/2014 12:46:42 PM

Monday, January 13, 2014 12:46:42 PM

Post# of 426470
sts66, I understand how you feel but if you would have read the SPA guidance document you would have read in section: B. Changes in Documented Special Protocol Assessments, pg 9-10 the following:

A clinical protocol assessment will no longer be considered binding if the director of the review division determines that a substantial scientific issue essential to determining the safety or efficacy of the drug has been identified after the testing has begun (section 505(b)(4)(C) of the Act).

http://www.fda.gov/downloads/Drugs/Guidances/ucm080571.pdf

Hey man don't shoot the messenger, these are the FDA own words, not mine.

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