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Alquest, Inc.
Alquest Support Yields FDA Approvals for Biotest Medical Diagnostics GmbH
September 12th, 2008
Alquest, Inc. - the leading contract research organization (CRO) specialized in medical and diagnostic devices - recently helped its client, Biotest Medical Diagnostics GmbH, earn BLA (biologics license application) approvals through the Office of Blood Research and Review in the Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration (FDA). The Aug. 14 FDA approvals covered BLA submissions for 26 monoclonal antibody based Blood Grouping Reagents; 2 Anti-human Globulin products; 13 Reagent Red Blood Cell products; and supplements to 3 previously licensed reagents. Keywords: Biologics, Biotechnology, Biotechnology...
Source: Health Business Week (2008-09-12)
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