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U.S. Department of Health and Human Services

Animal & Veterinary

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The Commissioner's Fellowship Program: Training FDA Ambassadors

by Laura Alvey, Deputy Director, Communications Staff
FDA Veterinarian Newsletter 2008 Volume XXIII, No VI

In the fall of 2008, the Food and Drug Administration launched a Commissioner’s Fellowship Program that provides an opportunity for health professionals and other scientists to receive training and experience within FDA.

The goal is to train a cadre of investigators intensively in the issues that relate to FDA regulatory science across devices, drugs (human and animal), biologics, foods (including animal feed), and cosmetics. Fellows train at FDA’s new state-of-the-art campus in White Oak, MD, or at other FDA facilities.

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 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.

Every regulatory decision made by FDA is based on science. Fellows explore the nature of these decisions with their preceptors and learn the scientific foundations upon which these decisions are made.

The coursework is designed to provide an in-depth review of the sciences behind regulatory review, encompassing the activities of FDA across foods, drugs, devices, and cosmetics. Coursework during the two years includes public policy, FDA law, leadership skills, epidemiology, clinical trials, statistics as well as devices and radiological health.

Overview

There is a wide range of training experiences at 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 as longer experiences in laboratories, epidemiological and behavioral areas, and in product review.

The FDA Commissioner’s Fellowship Program is not meant to replace the current fellowships and other educational experiences at FDA. The new program provides 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. In conjunction with this didactic training, Fellows, with the guidance of their preceptors, engage in a carefully designed and articulated FDA regulatory science project.

The intent of the Fellowship is to identify and train highly accomplished individuals who will be FDA ambassadors throughout their scientific careers. FDA anticipates that some of these Fellows would remain at FDA after their Fellowships. While others would seek jobs in industry where the knowledge and perspectives they gained would prove invaluable for their subsequent interactions with FDA and their contributions to regulatory science.

The FDA Commissioner’s Fellowship Program is designed for highly motivated and creative physicians, microbiologists, chemists, statisticians, physicists, physiologists, pharmacists, pharmacologists, engineers, food scientists, nutritionists, veterinarians, social scientists, epidemiologists, and other scientific professionals.

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.