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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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February 17, 2004 Approval Letter

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville MD 20852-­1448

February 17, 2004

Our STN: BL 103661/5019

Genzyme Biosurgery
Attention: Ann Price
Principal Associate, Regulatory Affairs
55 Cambridge Parkway
Cambridge, MA 02142

Dear Ms. Price:

Your request to supplement your biologics license application for Autologous Cultured Chondrocytes to utilize the BacT/Alert automated microbial detection system for the release of product based on interim negative results at approximately day 3 of a 14-day assay, as an alternate to the ---------- system, has been approved.

We acknowledge your letter of August 14, 2003 in which you have committed to perform side-by-side testing on contaminated clinical samples using the BacT/Alert and -----------systems for one year following approval of this supplement. Please submit this information in your next annual report indicating that this is a "non-506B post marketing commitment agreed upon during the review of the STN cited above." If this commitment is not completed at the time of submission of your next annual report, please include a status update on the progress towards completion of this commitment and a projected timeframe, noting your intention to report the findings in the next annual report. If the results of the side-by-side testing reveal a shorter time to detection for the ---------compared to the BacT/Alert system, please submit these results to CBER within 30 days of obtaining them.

This information will be included in your biologics license application file.

Sincerely yours,

--- signature ---

Raj K. Puri, M.D., Ph.D.
Acting Director
Division of Cellular and Gene Therapies
Office of Cellular, Tissue and Gene Therapies
Center for Biologics Evaluation and Research