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Information Request, November 4, 2011 - Hemacord

From: Thomas, Terrolyn

To: "Driscoll, Chris"; "Quinley, Eva";

cc:Quagraine, Mercy; Przepiorka, Donna; Bryan, Wilson; Simek, Stephanie; Benton, Kimberly;

Subject: URGENT: INFORMATION REQUEST
 

 

Date:  Friday, November 04, 2011 2:21:02 PM


**Please note, this information requested below is essential for the approval of your product. Please submit this information ASAP

 

Thanks
Terroyln

 


From: Thomas, Terrolyn

Sent : Monday, October 31, 2011 9:39 PM

To: "Driscoll, Chris"; "Quinley, Eva";

cc:  Quagraine, Mercy;

Subject: URGENT: INFORMATION REQUEST

 

Hello:

Please submit an Amendment to the BLA that says you are withdrawing your current clinical indication and submitting a new indication. This would be the broader one we are putting in the label . Please submit what is currently in the label.

 

Thanks
Terrolyn
Terrolyn B. Thomas, MS, MBA

Regulatory Project Manager
Office of Cellular, Tissue & Gene Therapies
CBER/FDA
1401 Rockville Pike HFM-705
Rockville, MD 20852-1448
Phone: 301-827-9161
Fax: 301-827-9796
Terrolyn.Thomas@fda.hhs.gov