FDA Commissioner’s Fellowship Program

Background

There is a wide range of training experiences at the FDA open to those who wish to acquire specific experiences in the sciences of FDA regulation. These include short term FDA training experiences as well longer experiences in laboratories, epidemiological and behavioral areas, and in product review.

Overview

The FDA Commissioner's Fellowship Program is not meant to replace the current fellowships and other educational experiences at the FDA, but rather to train a cadre of investigators intensively in the issues that relate to FDA regulatory science across devices, drugs, biologics, foods, and cosmetics. Exposure to FDA law, policy, the federal government budgeting process, networking and leadership skills, international activities, communication with the public and press, biostatistics, epidemiology, clinical trial design, risk assessment and risk management as well as extensive case-based learning are incorporated into the program. In parallel with this didactic training, the fellows, with the guidance of their preceptors, will engage in a carefully designed and articulated FDA regulatory science project.

In the medical, biological, mathematical risk management and statistical sciences, applicants are expected to have an M.D., D.V.M., Pharm.D, or Ph.D. degree or equivalent; for engineering applicants, a Bachelor's degree is required.

The intent of the fellowship is to identify and train highly accomplished individuals who will be FDA ambassadors throughout their scientific careers. We anticipate that some of these fellows would remain at the FDA after their fellowships. Others would seek jobs in industry where the knowledge and perspectives they gained would prove invaluable for their subsequent interactions with the FDA and their contributions to regulatory science.

The fellowship is designed as a 2-year program. Under the guidance of a preceptor (a senior FDA scientist committed to mentoring and selected by the Centers), fellows will explore in-depth a specific aspect of FDA regulatory science. The experience can be in a wet lab, with a clinical review or evaluation team, in biostatistics, informatics, epidemiology, risk analysis or another aspect of FDA science.

Details of Coursework and Scientific Experience

Year 1

Research: The fellows will be matched with an FDA preceptor during the selection process. The Center will identify the preceptors, who will in turn identify potential projects for the fellows. The first semester presents many short courses that examine core FDA functions. The first semester is not course-work intensive, allowing about 80% of the time to be devoted to the research project with the preceptor.

Semester 1 (October 2008 – December, 2008)

Course work:

October – December introductory courses

1. FDA and Public Policy
2. FDA Law
3. Negotiation and Leadership Skills
4. Communication with the Public and Press
5. Ethics
6. Budgets and Operations
7. Beyond our Borders

Research:

During this semester each fellow will work with her or his preceptor to develop a written research proposal that includes detailed literature review, methods to be used, anticipated outcomes, skills and techniques to be acquired. During this time, work on the project can begin, even as the formal proposal is developed. The proposal should highlight how skills learned in the didactic experiences will be incorporated into the fellow's scientific experience. Students will take examinations in December and June on the first year's coursework and present the formal research proposal to the preceptor for review.

Semester 2 (January – June 2009)

Course work:

January–June longitudinal courses

1. Statistical Methods and Applications [full semester]
2. Population science/ Epidemiology
3. Clinical trial design and evaluation [full semester]
4. Risk Assessment / Risk Management

Research: Students will spend about half time on their research work with research preceptors. They will present their research progress to their peers and the assembled research preceptors in June in short, 20 minute presentations.

The second semester will require about 50% time for coursework.

Summer Session (July – August, 2009)

Course work:

1. Formal 45 minute Research Presentations with critiques and feedback in content and presentation style to Center staff scientists.

Research: More than 90% of the fellows' time will be working on research projects.

Year 2:

Semester 3 (September – December 2009)

Course work:

These courses are essentially the core functions and science of the Centers and will be taught by the respective Centers.

1. Devices and radiological health
2. Foundations of toxicology
3. Understanding biologic agents and their evaluation
4. Understanding drugs and their evaluation
5. Food and nutrition safety
6. Surveillance and operations
7. Animal and human health: an inseparable link

Semester 4 (January – June 2010)

Course work:

1. Elective
2. Process Control Engineering and Chemistry (full semester)
3. Case studies in translational and regulatory science

Research: 80+% time on research project and in preparation for final presentation.

Fellowship ends in June 2010 with final presentations of research results to the Center Staff (in the Center they have chosen to do research) and project preceptors.

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