
Filing Memo Reminder Email, February 8, 2012 - Octaplas


 
 
 

From:                    Boxenbaum, Harold

Sent:                      Wednesday, February 08, 2012 12:34 PM

To:                         Rana, Pratibha; Lee, Timothy; Mahmood, Iftekhar; Stockbridge, Lisa L; Holobaugh, Patricia; Austin-Hansberry, Lori; Kim, Jessica; Rees, Renee; 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

Pratibha, 

 

Based on an evaluation, this BLA has no clinical pharmacology issues, and from our perspective, is fileable. Harold.

 

Harold Boxenbaum, Ph.D. 
FDA/CBER/OBRR 
WOC1 RM 402N 
1401 Rockville Pike 
Rockville, MD  20852

 

Phone: 301-827-6148 
Fax: 301-827-3533 
Harold.Boxenbaum@fda.hhs.gov

 

 

 

_____________________________________________

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

 