*Applications will be reviewed on a rolling-basis.
A research opportunity is currently available in the Office of New Drugs/ Office of Nonprescription Drugs (ONPD), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) located in Silver Spring, Maryland.
Many nonprescription products in the United States are marketed under the OTC monograph. Unlike FDA-approved products, individual OTC monograph products are not evaluated in clinical trials, and the formulation is not approved by FDA before marketing. These products may contain novel inactive ingredients that are not present in FDA-approved drug products, with unknown toxicities. The project will determine the percentage of OTC monograph pediatric cough and cold products (or drugs in another category) that contain ingredients not present in approved drug products, and start to identify those inactive ingredients that may pose a safety risk.
The participant will gain an understanding of how nonprescription drug products are marketed in the United States. In addition, the participant will gain experience in leveraging information from internal databases to identify inactive ingredients unique to OTC monograph products, and learn how to assess the safety of inactive ingredients.
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.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2021-0608) in your email.