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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Meeting Cover Letter - Bivigam

 

Our Reference: CRMTS #8670                                              Division of Blood Applications
                         STN 125389/0                                               Telephone: (301) 827-3524
 
 
Biotest Pharmaceuticals Corporation
Attention: Gary Ingenito, M.D., Ph.D.
5800 Park of Commerce Boulevard., N.W.
Boca Raton, FL  33487
 
Dear Dr. Ingenito:
 
Attached is a copy of the memorandum summarizing your September 10, 2012 Type A meeting with CBER. Please note that although cited in the summary, we have not attached copies of materials you supplied. This memorandum constitutes the official record of the meeting. If your understanding of the outcomes differs from those expressed in this meeting summary, it is your responsibility to bring these discrepancies to CBER’s attention for resolution.
 
If you have any questions, please contact Pratibha Rana at (301) 827-6124.
 
Sincerely yours, 
 
 /s/
 
Iliana Valencia, M.S.
Chief, Regulatory Project
 Management Branch
Office of Blood Research and Review
Center for Biologics
 Evaluation and Research