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Vaccines, Blood & Biologics
Filing Meeting Summary - XYNTHA
Pauline Cottrell, DBA, HFM-380
Filing Meeting Summary for STN:125264/0
Pauline Cottrell, Tim Lee, Nisha Jain, Paul Buehler, Iftekhar Mahmood, Boris Zaslavsky, Catherine Miller, Bhanu Kannan, Daniel Kearns
Antihemophilic Factor (Recombinant), Plasma/Albumin Free
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.