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
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
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.