Beth Goldstein
Public Health Analyst, 505(B)(2) Team, Office of New Drugs (Ond), Office of New Drug Policy (Ondp) at Fda
Based in Silver Spring, United States
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Seniority
Staff
Department
Public Administration & Safety
Location
Silver Spring
Industry
Government Administration
Company size
17K
Contact information
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b•••••••@fda.gov
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Background
About Beth Goldstein
Public Health Analyst with almost 29 years of experience at the Food and Drug Administration (FDA). Preeminent experience and expertise in leading the 505(b)(2) new drug application regulatory program in the Center for Drug Evaluation and Research’s (CDER) Office of New Drugs (OND). Served as OND’s Associate Director for Regulatory Affairs under the OND Director and has vast additional experience in areas of regulatory affairs, regulatory policy, postmarketing commitments/requirements, strategic process development, and regulatory health project management. Proven leader with deep expertise in drug development and regulatory pathways, stakeholder engagement, and cross-functional team leadership. Adept at guiding sponsors and applicants through complex regulatory landscapes. Effective communicator, trainer, and mentor to both internal staff and external stakeholders.
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