Scientific Review Process at the U.S. Food and Drug Administration
FOURTH CONFERENCE OF ROMANIAN AMERICAN PROFESSIONALS
VESTED IN WEAVING SOCIAL COHESION
2nd Day, Professionals in Biomedical Sciences, STEM and IT Panel, Dec. 3rd 2022
Dr. Simona Puiu, Scientific Review Officer at U.S. Food and Drug Administration. She spoke of her sinuous career path from her inorganic chemist specialization at Babes-Bolyai University, Cluj-Napoca to her doctorate from Georgetown University and the many exciting private sector research labs that used her expertise to bring various products to the market. That private sector research and development experience proved vital in informing her current position as reviewer for the FDA. Her presentation provides insights into the formal review process and the various levels of scientific scrutiny that medical product must undergo to be approved on the US market.