Martha Nguyen
Division Director, Generic Drug Policy Development at Food and Drug Administration
- Role
- Director, Division of Policy Development, Cder Office of Generic Drugs at FDA
- Location
- Washington, DC, US
- LinkedIn followers
- 500 followers
About Martha Nguyen
I have almost three decades of strategic healthcare policy and public policy experience, honed at multiple law firms, government agencies, and nonprofit think tanks in Washington, DC. I currently serve at the Food & Drug Administration, providing strategic leadership and direction on broad generic drug regulatory policy issues and overseeing the development, clearance, and publication of all regulations, guidances, and other policy documents affecting generic drugs. I am a collaborative leader, a creative problem solver, a strong writer, and an effective public speaker, known for achieving timely results and building strong working relationships based on trust and mutual respect. I have a Bachelors Degree in Sociology of Health and Medicine from the University of Pennsylvania and a Juris Doctorate from the Georgetown University Law Center.
Experience
Director, Division of Policy Development, Cder Office of Generic Drugs
Jan 2014 — Present · Washington, DC, US
Provide strategic leadership and direction to the Office of Generic Drugs on broad policy issues affecting generic drugs. Oversee the development and clearance of regulations, guidances, 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). Advise internal and external stakeholders on current and emerging issues related to generic drug regulation and identify and implement proposed policy solutions.
Education
Connelly School of the Holy Child
High School Diploma
1991 — 1995
Georgetown Law
JD, Law
2000 — 2003
University of Pennsylvania
BA with Honors Distinction, Sociology of Health and Medicine
1995 — 1999
Skills
- Policy Analysis
- Regulatory Analysis
- Legislative Relations
- Generic Drugs
- Drug Development
- Drug Safety
- Regulatory Strategy Development
- Prescription Drugs
- Regulations
- Regulatory Policy
- Health Law
- Westlaw
- Rulemaking
- Legislative Policy
- Federal Government
- Food & Drug Law
- Public Policy
- Administrative Law
- Legal Writing
- Legal Research
- Legislation
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.