Speakers

Gisa Perez is the Generics Branch Chief in the Division of User Fee Management, Office of Management in FDA’s Center for Drug Evaluation and Research. This Branch is responsible for accessing user fees under the Generic Drug User Fee Amendments (GDUFA). Gisa has been working on GDUFA matters since its inception in 2012. She was part of the user fee implementation team and worked on various projects that contributed to GDUFA’s success. Prior to joining the Office of Management, Gisa Perez worked at the Office of New Drugs (OND) in the Program Management and Analysis Staff.  She earned her BS in Computer Sciences in 2004 and an MBA in 2010, both from University of Maryland.