Product Approval Information
MEMORANDUM
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research
| DATE | June 8, 2007 |
| FROM | Bhanu Kannan, Bioresearch Monitoring Branch, HFM-664 Division of Inspections and Surveillance Office of Compliance and Biologics Quality |
| TO | Timothy Lee, HFM-392 Chair, BLA Licensing Committee |
| SUBJECT | Filing Memo SPONSOR: Wyeth PRODUCT: Moroctocog alfa (AF-CC) BLA: STN 125264/0 |
Summary:
Our review of the BLA submission notes that there are no filing issues and the filing of the submission appears to be adequate for the Bioresearch monitoring review purposes.
Should you have any questions or comments about the contents of this memo or any aspect of Bioresearch Monitoring, please contact me at 301-827-6188.
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Bhanu Kannan