*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), Office of Translational Sciences/Office of Clinical Pharmacology/Division of Applied Regulatory Science (DARS) in Silver Spring, Maryland.
The Overdosage Section of many labels have not been updated and now contain harmful treatment recommendations. The Overdosage Sections of generic versions of drugs and within drug classes may be significantly different, when the language should be similar. There have been initiatives to update the Overdosage Section of the labels with significant improvements, but more work is needed. Under the guidance of the mentor, the participant will gain knowledge in Clinical Pharmacology/Toxicology for various drugs, and learn regulatory practice for updating drug labels.
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 in your email.