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Vaccines, Blood & Biologics

Request for Additional Information Email, May 15, 2009 - Adenovirus

From:                     Hithe, Darlene
Sent:                      Friday, May 15, 2009 10:56 AM
To:                         'Pakulski, John'
Cc:                         Miller, Daryll L
Subject:                 BLA125296 Request for additional information

Importance:           High

Dear John,

Your BLA is under review by CBER and we have the following comment in regard to post-marketing surveillance.  Please submit your response as an amendment to the BLA by May 22, 2009, in order to avoid an extension of the review clock. 

In the Sentinel Surveillance Plan, Appendix A - Predefined List of Medical Events of Interest, ICD-9 code 995.0 for other anaphylactic shock was listed as the only code for anaphylaxis.  Since anaphylactic shock is usually referred as the most severe manifestation of anaphylaxis, please add additional ICD-9 codes to expand the search for anaphylaxis.

Please consider this e-mail as a formal request for information.  No fax or letter will be sent separately.

Best Regards,

Darlene Hithe
Regulatory Project Manager
1401 Rockville Pike, HFM-478
Rockville, MD 20852-1448
Tel.:  301-827-3070
Fax:  301-827-3532
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