Bazarragchaa Damdinsuren, M.D. is Drug Quality Reviewer, Office of Biotechnology Products, Office of Pharmaceutical Quality, CDER, FDA. Bazarragchaa Damdinsuren received his M.D. from National Medical University in Mongolia and his Ph.D. from Osaka University, Japan. He holds Regulatory Affairs Certification (RAC) by the Regulatory Affairs Professionals Society (RAPS). He has published over 40 scientific articles.
After completion of his postdoc in immunology and cell biology at the National Institutes of Health (NIH), Damdinsuren joined the FDA as a Commissioner’s Fellow in 2010. At his current position in the Office of Biotechnology Products, he is responsible for reviewing the product quality and manufacturing controls of therapeutic monoclonal antibodies, antibody derivatives (Fc fusion proteins, Fab, etc.), antibody drug conjugates, and biosimilars to antibody products.