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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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1/9/2008 Pediatric Deferral Email - RECOTHROM

From: Jain, Nisha
 
Sent: Wednesday, January 09, 2008 12:10 PM
To: 'MAGU (Mark Gauthier)'
Cc: Drews, Roman T; Shields, Mark
Subject: RE: Pediatric Deferral

Hi Mark,

As communicated to you during our telephone conversation, please submit the following:

expand age group to include newborns
provide scientific rationale to support extrapolation of efficacy from adults

Nisha


 

From: MAGU (Mark Gauthier) [mailto:gauthiem@zgi.com]
 
Sent: Tuesday, January 08, 2008 8:19 PM
To: Jain, Nisha
Subject: Pediatric Deferral

Hi Nisha,

I forgot to ask what time the Pediatric Subcommittee meeting is taking place. Would you send me an email note after the meeting and let me know what the outcome is either way? That way I will know if this is resolved based on what we already submitted (ideal) or if we need to send you the synopsis that will be finalized tomorrow.

Thank you,

Mark

 

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