FDA
Silver Spring, MD, United States
Dr. Nikolay P. Nikolov is a board-certified Internist and Rheumatologist who joined FDA in 2009 as a Medical Officer, and is currently the Director of the Division of Rheumatology and Transplant Medicine, CDER.
He completed his Internal Medicine residency at Lincoln Medical Center, Bronx, NY and then joined National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), NIH, where he completed his rheumatology fellowship, participated in clinical investigational protocols and studied cellular and molecular mechanisms of autoimmunity in animal models in the Immunoregulatory Group, Autoimmunity Branch at NIAMS. In 2005, Dr. Nikolov joined the Sjögren's Syndrome Group at the National Institute of Dental and Craniofacial Research, NIH, as a clinical investigator where he conducted clinical and translational studies in systemic lupus erythematosus (SLE) and Sjögren's syndrome.
At the FDA Dr. Nikolov is involved in the regulatory review of immuno-modulatory therapies, including small molecules, biologics and biosimilars, for the treatment of pediatric and adult rheumatologic diseases. He has participated in the development of the Agency's policies and regulatory decisions in these areas.
Disclosure information not submitted.
Monday, November 14, 2022
5:15 PM – 5:30 PM Eastern Time
