From: Cordaro, Debbie [mailto:Debbie.Cordaro@fda.hhs.gov]
Sent: Fri 7/15/2011 4:54 AM
To: Jennifer Spinella
Subject: FW: RDT Protein specification change 125335/0
In a email from earlier this week, we raised the issue of changing the protein specification from '(b)(4)' to xxx mg/vial. There was no request included to inform us if you agreed to this, but it is a matter of some urgency, since the PI, carton labels, and approval letter will need that 'xxx' number. Can you just email your decision regarding this and what the number/mg/vial has been determined to be.
Regulatory Project Manager
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