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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Extension of Action Due Date Email, October 17, 2012 -Octaplas

 

From:                    Frost, Mitchell M
Sent:                      Wednesday, October 17, 2012 3:51 PM
To:                         Rana, Pratibha
Cc:                         Jain, Nisha
Subject:                 Octaplas 125416: Extension of Action Due Date
 
The action due date for Octaplas BLA 125416 is extended 3 months due to the submission of Amendment 12 on August 13, 2012. This amendment contains substantial clinical data for review that qualifies it to be classified a major amendment. 
 
*****************************************
Mitchell Frost
Medical Officer
FDA/CBER/OBRR/DH/CRB
1401 Rockville Pike, Ste. 430N
Rockville, MD 20852
Phone: 301-827-2695
E-mail: Mitchell.Frost@fda.hhs.gov