Martha Nguyen

Martha Nguyen is the Director of the Division of Policy Development in FDA CDER's Office of Generic Drugs, where she provides strategic leadership and direction on broad policy issues affecting generic drugs and oversees the development and clearance of regulations, guidance documents, policies, procedures, statements of policy, and programs affecting regulation of generic drug products, including implementation and reauthorization of the Generic Drug User Fee Amendments (GDUFA). Ms. Nguyen previously worked at a Washington, DC, law firm and in CDER’s Office of Regulatory Policy before joining the Office of Generic Drugs in 2014. She holds a JD from the Georgetown University Law Center and a BA from the University of Pennsylvania.