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Re: Biobillionair post# 22236

Wednesday, 11/27/2013 7:29:53 PM

Wednesday, November 27, 2013 7:29:53 PM

Post# of 426469
BB,

This paragraph tells me nothing has changed.


Also within 14 days, amend all pending supplemental applications that includes labeling changes for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the changes approved in this supplemental application

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