*Applications will be reviewed on a rolling basis.
An opportunity is available at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) in the Office of New Drugs/ Immediate Office (IO). This opportunity will be located at the National Center for Toxicological Research (NCTR) in Jefferson, Arkansas. 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.
FDA/CDER has recently become aware of a newly recognized class of drug impurities and degradation products that are formed from the drug substance itself (referred to a N- nitroso Drug-Substance-Related Impurities, NDSRIs). Because of the structure of these impurities, many could pose a significant cancer risk to patients using medications that contain them. This project will establish short-term tests for evaluating the cancer risk of NDSRIs, using the methods to develop data on this largely unknown class of compounds to populate FDA’s in silico prediction tools to limit health risks from these impurities in drug products.
Under the guidance of the mentor, the participant will learn how science can be used to address a major regulatory issue for CDER. The participant will plan, execute, and interpret research that will develop an optimized approach for evaluating the potential cancer health risks associated with a newly recognized class of drug impurities and degradation products.
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 Jefferson, Arkansas, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.