FDA Product Specific Guidance and Research Fellowship

A research opportunity is available at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Generic Drugs/ Office of Research and Standards, Immediate Office located in Silver Spring, Maryland. CDER performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.

This project explores knowledge management systems for FDA-funded scientific research, CDER approved drug products, CDER published guidance including product-specific guidance, as well as the refinement of processes and infrastructure to analyze and track how research outcomes from FDA-funded scientific research can be used to support product-specific guidance development. This project includes the development of novel knowledge management and research management tools to maintain, monitor, and analyze how the impact of outcomes from a scientific research program can be maximized to support decision making.

The participant will gain insight into the FDA's Office of Generic Drugs, and how their research supports guidance development and regulatory decision making, as part of the Generic Drug User Fee Amendments (GDUFA) Program.

This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The initial appointment is for one year, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.

Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.

FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency. This agreement covers such topics as the following: