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U.S. Department of Health and Human Services

About FDA

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Coursework Details

Year 1

Semester 1 (January - April)

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

  1. FDA History and Alumni Perspectives and Key Issues Facing the FDA
  2. FDA Policy and Regulatory Processes
  3. FOI Overview

Research

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.

Semester 2 (February – June)

Coursework

  1. Fundamentals of Epidemiology
  2. FDA 101

Research

Students will spend about 15 percent of their scheduled time focusing on graduate-level coursework.

Summer Session 1 (June – September)

Coursework

  1. Biotechnology:  Management of Drug Discovery
  2. Budgets, Operations, and Planning

Research

Approximately 85 percent of the Fellows' scheduled time will be spent on their research project. Fellows will give formal presentations to the Fellowship Committee, other Fellows, and Preceptors addressing the public health impacts of their projects.

Year 2

Semester 3 (October – March)

Coursework

  1. Introduction to Clinical Trials
  2. Topics in Clinical Trials

Research

Fellows will spend about 15 percent of their scheduled time focusing on graduate-level coursework.

Semester 4 (February – May)

Coursework

  1. Clinical Pharmacology/Pharmacokinetics
  2. Introduction to Toxicology

Research

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

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.

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