
Filing Meeting, February 8, 2012 pm - Octaplas

 

 
 

From:                    Wyatt, Michael (Keith)

Sent:                      Wednesday, February 08, 2012 12:18 PM

To:                         Rana, Pratibha

Cc:                         Kirschbaum, Nancy; Mahmood, Iftekhar

Subject:                 Filing Meeting/STN 125416/0/OctaplastLG/Pratibha

Dear Pratibha

 

Based on a cursory review of the Octaplas LG submission, STN 125416/0, I have not identified any pharm/tox issues that would prevent this BLA from being filed.

 

Keith

 

M. Keith Wyatt, Ph. D.

Pharmacologist

Food and Drug Administration

CBER/OBRR/DH HFM-392

1401 Rockville Pike

Rockville, MD 20852-1448

 

(301) 827-9258

(301) 827-3534 (fax)