Speakers

Since 2014, Martha

Division Director, OGDP, OGD, CDER, FDA

Nguyen has served as the Director of the Division of Policy Development in FDA CDER OGD’s Office of Generic Drug Policy, where she provides strategic leadership and direction on broad generic drug regulatory policy issues.  She oversees the development and clearance of regulations, guidance documents, and statements of policy affecting regulation of generic drug products, including reauthorization and implementation of the Generic Drug User Fee Amendments (GDUFA).  Ms. Nguyen has nearly three decades of strategic health policy experience, honed at several nonprofit think tanks and law firms in Washington, DC, and in CDER’s Office of Regulatory Policy prior to joining OGD.  She earned a JD from the Georgetown University Law Center and a BA in Sociology of Health and Medicine from the University of Pennsylvania.