Natalya Ananyeva


Natalya Ananyeva, PhD is a Regulatory Review Scientist in the Division of Plasma Protein Therapeutics (DPPT) in the Office of Tissues and Advanced Therapies (OTAT) in the Center for Biologics Evaluation and Research (CBER), FDA. Natalya joined the FDA in 2009 and has performed evaluation of information on Chemistry, Manufacturing and Controls (CMC) in various regulatory submissions (INDs, BLAs, BLSs) as it relates to the quality and safety of biological products indicated for the treatment of congenital or acquired bleeding disorders, specifically coagulation factors (both plasma-derived and recombinant), fibrin sealants and their biologics/device combination products, and plasma-for-transfusion products. Her scientific expertise is in molecular biology, biochemistry and cell biology. Currently, Dr. Ananyeva is Team Lead in the Hemostasis Branch of DPPT/OTAT.