Vaccines, Blood & Biologics
Resources for You
RDT Protein Specification Change Email, July 15, 2011 - Anascorp
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
THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please immediately notify the sender by e-mail or phone.