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

 

From:                    Ovanesov, Mikhail V.

Sent:                      Wednesday, February 08, 2012 11:17 AM

To:                         Kirschbaum, Nancy

Cc:                         Rana, Pratibha; Lee, Timothy

Subject:                 RE: Reminder Filing memo due: Filing Meeting/STN 125416/0/OctaplastLG/Pratibha

Dear Nancy,

 

I briefly reviewed the sections of the submission assigned to me:

3.2.S.3.1              Characterization

3.2.P.3.4              Control of Critical Steps and Intermediates

3.2.P.5.3              Analytical Methods Validation

3.2.P.5.5              Impurities

 

The submission can be filed from my discipline's point of view.

 

This e-mail should serve as my filing memo.

 

Thank you,

--mikhail

 

Mikhail V. Ovanesov, Ph.D.

Visiting Scientist, Principal Investigator

Laboratory of Hemostasis / Division of Hematology / Office of Blood Research and Review

Center for Biologics Evaluation and Research / U.S. Food & Drug Administration

Office: (301) 827-4026 Fax: (301) 402-2780 Cell: (240) 731-0308

E-mail: mikhail.ovanesov@fda.hhs.gov

29 Lincoln Drive, N29/309, Bethesda, MD 20892                                                     

Mail: FDA/CBER ; HFM 340 ; 1401 Rockville Pike, Rockville, MD 20852

 

 

_____________________________________________
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