


Meeting Response Email, April 24, 2013 - Hyqvia




  From: Shields, Mark
Sent: Wednesday, April 24, 2013 3:08 PM
To: Blackshere, Angela L
Subject: RE: 125402/0/26 CRMTS 8779 Immune Globulin Infusion( Human), 10% 
(rHuPH20)

Attachments: CRMTS#8779 Meeting Response April 24 2013 (2).cert.pdf

Hello Angela,

The agency does not feel that a meeting is appropriate until you have responded 
to our 16-Apr-2013 Information Request and considered our responses to the 
meeting questions (attached).

Best Regards
Mark A. Shields, RAC
Regulatory Project Manager
HFM-380  FDA/CBER
Office of Blood Research and Review
Division of Blood Applications
301-827-6173 fax 301-827-2405
email: mark.shields@fda.hhs.gov
1401 Rockville Pike
Rockville, MD 20852-1448

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