Maria Gutierrez-Lugo, PhD

Review Chief, Division of Biotechnology Review and Research III, OBP, OPQ, CDER

Dr. Gutierrez-Lugo is a Product Quality Review Chief in the Office of Biotechnology Products (OBP), OPQ, CDER, FDA where she oversees the review of monoclonal antibodies and other biotechnology products, including biosimilars from development, license applications, and post-approval. Prior to joining the FDA in 2008, Dr. Gutierrez-Lugo conducted postdoctoral research at the NIH and at the University of Arizona. She holds a Ph.D. in Chemical Sciences (Pharmacy) from the National Autonomous University of Mexico.

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