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Filing Memo Reminder Email, February 8, 2012 pm - Octaplas

 

From:                    Mullersman, Jerald
Sent:                      Wednesday, February 08, 2012 3:25 PM
To:                         Rana, Pratibha; Lee, Timothy; Mahmood, Iftekhar; Stockbridge, Lisa L; Holobaugh, Patricia; Austin-Hansberry, Lori; Kim, Jessica; Rees, Renee; Boxenbaum, Harold; Green, Damon; Kirschbaum, Nancy; Drabick, Christine; Malla, Amy; He, Jie; Brony, Michael; Frost, Mitchell M; Kirschbaum, Nancy; Kim, Jessica; Melhem, Randa; Peng, Ze; Ovanesov, Mikhail V.; Wyatt, Michael (Keith)
Cc:                         Nguyen, Michael D.
Subject:                 RE: Reminder Filing memo due: Filing Meeting/STN 125416/0/OctaplastLG/Pratibha
Pratibha,
 
As I noted in the meeting yesterday, the OctaplasLG BLA submission, while fileable, does not include a pharmacovigilance plan. Here is some letter-ready text (in quotes below) that might be included in the filing memo that is being sent to Octapharma:
 
"Pursuant to the ICH E2E Pharmacovigilance Planning Guideline April 2005, it is recommended that Octapharma submit a pharmacovigilance plan containing the elements delineated in the ICH E2E guidelines (which can be accessed at http://www.fda.gov/RegulatoryInformation/Guidances/ucm129411.htm). Rapid submission of this plan in a complete form will facilitate timely review of the application."
 
Thanks,
 
Jerry Mullersman
 
Jerald Mullersman, MD, PhD, MPH
Medical Officer
FDA/CBER/OBE/DE/PVB HFM-224
1401 Rockville Pike, Suite 400 S
Rockville, MD 20852
 
Office: (301) 827-2952
 
_____________________________________________
From:                    Rana, Pratibha 
Sent:                      Wednesday, February 08, 2012 11:14 AM
To:                         Lee, Timothy; Mahmood, Iftekhar; Stockbridge, Lisa L; Holobaugh, Patricia; Austin-Hansberry, Lori; Kim, Jessica; Rees, Renee; Boxenbaum, Harold; Green, Damon; Kirschbaum, Nancy; Drabick, Christine; Malla, Amy; He, Jie; Brony, Michael; Frost, Mitchell M; Kirschbaum, Nancy; Mullersman, Jerald; Kim, Jessica; Melhem, Randa; Peng, Ze; Ovanesov, Mikhail V.; Wyatt, Michael (Keith)
Subject:                 RE: Reminder Filing memo due: Filing Meeting/STN 125416/0/OctaplastLG/Pratibha
 
 
Please don’t forget to Cc your supervisor also if you are writing an email.
Thanks
Pratibha
_____________________________________________
From:                    Rana, Pratibha 
Sent:                      Wednesday, February 08, 2012 11:06 AM
To:                         Jain, Nisha; Lee, Timothy; Mahmood, Iftekhar; Stockbridge, Lisa L; Holobaugh, Patricia; Austin-Hansberry, Lori; Kim, Jessica; Rees, Renee; Boxenbaum, Harold; Green, Damon; Kirschbaum, Nancy; Drabick, Christine; Malla, Amy; He, Jie; Brony, Michael; Frost, Mitchell M; Kirschbaum, Nancy; Mullersman, Jerald; Kim, Jessica; Melhem, Randa; Peng, Ze; Ovanesov, Mikhail V.; Wyatt, Michael (Keith)
Subject:                 Reminder Filing memo due: Filing Meeting/STN 125416/0/OctaplastLG/Pratibha
 
Hello All,
This is a reminder to upload your signed off Filing memo by Friday February 10, 2012.
If you are writing a filing memo as email please CC me and the chairperson, Nancy Kirshbaum.
Thanks
Pratibha
 
_____________________________________________
From:                    Rana, Pratibha 
Sent:                      Thursday, January 05, 2012 1:38 PM
To:                         Rana, Pratibha; Rana, Pratibha; Jain, Nisha; Lee, Timothy; Mahmood, Iftekhar; Stockbridge, Lisa L; Holobaugh, Patricia; Austin-Hansberry, Lori; Kim, Jessica; Rees, Renee; Boxenbaum, Harold; Green, Damon; Kirschbaum, Nancy; Drabick, Christine; Malla, Amy; He, Jie; Brony, Michael; Frost, Mitchell M; Kirschbaum, Nancy; Mullersman, Jerald; Kim, Jessica; Melhem, Randa; Peng, Ze; Ovanesov, Mikhail V.; Wyatt, Michael (Keith)
Subject:                 Filing Meeting/STN 125416/0/OctaplastLG/Pratibha
When:                    Tuesday, February 07, 2012 1:00 PM-2:00 PM (GMT-05:00) Eastern Time (US & Canada).
Where:                  CBER Conf. WOC-400S
 
( if you are unable to attend in person and by phone) please send an email answering the following topics to SL, Nancy Kirshbaum and me).
 
STN 125416/0
Product: Pooled Plasma, Solvent Detergent Treated (Human)
Sponsor: Octapharma
 
Filing Meeting:
To determine if this BLA is fileable/RTF/Deficiencies
Decision on priority review or not
 
 
Call in info for those who cannot attend in person:
 
------(b)(4)---------
Participant code: ---(b)(4)----
 
Thanks
Pratibha