Filing Meeting Summary - XYNTHA
 
MEMORANDUM

Date: 6-Jun-07

From: Pauline Cottrell, DBA, HFM-380

RE: Filing Meeting Summary for STN:125264/0

ATTENDEES: Pauline Cottrell, Tim Lee, Nisha Jain, Paul Buehler, Iftekhar Mahmood, Boris Zaslavsky, Catherine Miller, Bhanu Kannan, Daniel Kearns

Sponsor: Wyeth

Product: Antihemophilic Factor (Recombinant), Plasma/Albumin Free

DUE DATE: 22-Feb-08

TO: File

The SL indicated to me that STN: 125264/0 Antihemophilic Factor (Recombinant), Plasma/Albumin-free from Wyeth requesting CBER to eliminate the use of animal-and human-derived proteins resulting in the development of the ReFacto AF manufacturing process, may be filed. He may later request additional clarification of some of the information/data submitted.
