
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