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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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RDT Protein Specification Change Email, July 15, 2011 - Anascorp

-----Original Message-----
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

Hi Jennifer,

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.

Thank you,
Debbie

Debbie Cordaro
Regulatory Project Manager
FDA/CBER/OBRR
Voice: 301-827-6157
debbie.cordaro@fda.hhs.gov

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