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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Filing Meeting Summary - January 6, 2009

DATE:      January 6, 2009             2- 3:00 p.m.

FROM:     Debbie Cordaro DBA, HFM-370

RE:           125329/0; Filing meeting

Attendees: 

                  Michael Kennedy, Margorzata Mikolajcxyk, Douglas Frazier, Ann Gaines, Craig Zinderman, Anthony Hawkins, Hon-Sum Ko, Iftkhar Mahmood, Xue (Mary) Lin, Evi Struble, Lisa Stockbridge, Pei Zhang, Lilin Zhong, Debbie Cordaro and Kelly Lewis

Sponsor: Bio Products Laboratory               

Product:  Immune Globulin Intravenous (Human)

Due Date: September 17, 2009

To:          File

Margaret Mikolajczyk: Agrees to file, but notes the submission is missing bioburden data, endotoxin specifications, and a summary of the in-process QC  results.

 

Pei Zhang: Agrees to file.

Evi Stuble: Agrees to file, but will request a CoA.

Hon-Sum Ko: Agrees to file.

Mary (Xiu) Lin: Agrees to file.  She requests they send a new AEX.xpt file.

Lisa Stockbridge: The proprietary name was reviewed under IND.  They need to submit the SPL in PLR format.

Iftekhar Mahmood: Agrees to file, but will request the PK data in Excel format.

Jim Crim: Agrees to file

Michael Kennedy:  Agrees to file

Ann Gaines: Agrees to file, but the firm must submit their pharmacovigilence plan.