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U.S. Department of Health and Human Services

About FDA

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Project and Course Details

Year 1

Semester 1 (January - April)

Research Project
During this semester each Fellow will work with his or her Preceptor to develop a written research proposal that includes detailed literature review, methods to be used, anticipated outcomes, and skills and techniques to be acquired. Work on the project can begin even as the formal proposal is developed.
The first semester presents several short introductory courses that examine core FDA functions. Fellows will spend about 20 percent of their scheduled time completing these courses.

Coursework
• FDA History and Alumni Perspectives and Key Issues Facing the FDA
• FDA Policy and Regulatory Processes
• FOI Overview

Semester 2 (February – June)

Research Project
Fellows will spend about 85 percent of their time on their research and 15 percent of their scheduled time focusing on graduate-level coursework.

Coursework
• FDA 101
• Fundamentals of Epidemiology
 

Summer Session 1 (June – September)

Research Project
Fellows will spend about 85 percent of their time on their research and 15 percent of their scheduled time focusing on graduate-level coursework.
Fellows will give formal presentations to the Fellowship Committee, other Fellows, and Preceptors addressing the public health impacts of their projects.

Coursework
• Biotechnology: Management of Drug Discovery
• Budgets, Operations, and Planning

Year 2

Semester 3 (October – March)

Research Project
Fellows will spend about 85 percent of their time on their research and 15 percent of their scheduled time focusing on graduate-level coursework.

Coursework
• Introduction to Clinical Trials
• Topics in Clinical Trials

Semester 4 (February – May)

Research Project
Fellows will spend 90 percent of their scheduled time conducting research relevant to their research projects.

Coursework
• Clinical Pharmacology/Pharmacokinetics
• Introduction to Toxicology

Summer Session 2 (June – October)

The Fellowship ends in October with final presentations of research results to Preceptors, Fellows, and Center staff. In the months leading up to the final presentations, Fellows are expected to focus on finalizing their projects.

*Please note that all courses will be taught at the White Oak Campus in Silver Spring, Maryland. Remote access will be provided for Fellows at remote FDA locations.
**The courses that are instructed at the graduate-level may require commitment outside of the traditional work schedule.