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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.
Iliana Valencia, M.S.
Chief, Regulatory Project
Office of Blood Research and Review
Center for Biologics
Evaluation and Research