Product Approval Information
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.