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NoPinkScams

02/19/15 11:30 AM

#46422 RE: tjshooker #46421

No, the FDA didn't make a clerical error. Regenesis did. They marked their response confidential and the FDA treated it as such.
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seven-up

02/19/15 11:33 AM

#46423 RE: tjshooker #46421

tjshooker it was not the fda mistake

Upon further review, we have noted
that the comment submitted to FDA stated "CONFIDENTIAL" in the footer. We do this as a matter of habit with extemal communications and this was done in error. We apologize for any
confusion this may have caused.
The comments submitted to FDA are not confidential and we are requesting that Regenesis' comment noted under FDA-2012-N-0378-DRAFT-0315 be posted to the regulations.gov website.