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Monoclonal antibodies office - PowerPoint PPT Presentation

FDA TSE Advisory Committee Meeting February 13, 2004; Topic 4D Minimizing the Risk of TSE in CDER - Regulated Products

FDA TSE Advisory Committee Meeting February 13, 2004; Topic 4D Minimizing the Risk of TSE in CDER - Regulated Products. Gerald M. Feldman, Ph.D. Division of Monoclonal Antibodies Office of Biotechnology Products Office of Pharmaceutical Science Center for Drug Evaluation and Research.

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266 views • 12 slides

Romiplostim Amgen, BLA #125268

Romiplostim Amgen, BLA #125268. David Frucht, M.D. Product Quality Reviewer Division of Monoclonal Antibodies Office of Biotechnology Products. Cellular Target: TPO Receptor (Mpl). T P O. Thrombopoietin (TPO) :

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517 views • 6 slides

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Monoclonal antibodies office - PowerPoint PPT Presentation

FDA TSE Advisory Committee Meeting February 13, 2004; Topic 4D Minimizing the Risk of TSE in CDER - Regulated Products

Romiplostim Amgen, BLA #125268