Fabiola C. Gomez, Ph.D.

Dr. Gomez was a senior product quality reviewer in the Office of Pharmaceutical Quality in CDER/FDA for more than eight years specializing in biotechnology products. She has a strong expertise in reviewing complex 351(a) original and 351(k) submissions, ensuring compliance with regulatory standards, and conducting inspections of manufacturing facilities for biotechnology products. As a product quality reviewer, she contributed to FDA guidance and knowledge-management initiatives.

Later in her FDA career, Dr. Gomez served as a Health Scientist in CDER’s Office of Communications, where she led the CDER Network of Experts program by facilitating communication and enhancing collaboration between FDA and stakeholders to address scientific and medical issues.

Dr. Gomez has four years of chemical synthesis in inorganic chemistry and more than nine years of translational research experience in oncology. She has presented at multiple scientific meetings and has 13 scientific publications in peer-reviewed journals.