Former FDA CMC Reviewer Joins Law Firm

Former CDER chemistry, manufacturing and controls (CMC) reviewer Fabiola Cervantes-Gomez has joined Hyman, Phelps & McNamara’s CMC regulatory expert team. According to the law firm, Cervantes-Gomez spent more than eight years at CDER, where she reviewed biotechnology products ranging from monoclonal antibodies and antibody-drug conjugates to biosimilars. She served as a primary CMC assessor for multiple BLA and IND submissions across oncology, rare diseases and other therapeutic areas.

er FDA experience also includes conducting manufacturing-facility inspections, contributing to agency guidance development, and leading CDER’s Network of Experts Program, which coordinates scientific engagement between FDA staff and external professional organizations.

Cervantes-Gomez holds a Ph.D. in biomedical sciences from the University of Texas Health Science Center at MD Anderson Cancer Center and a B.S. in chemistry from the University of Texas at El Paso.