*Applications will be reviewed on a rolling- basis.
The Center for Drug Evaluation and Research (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 U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.
The aim of this project is to research model- informed approaches, including strategies for prioritizing product-specific guidance development, to facilitate the availability and accessibility of generic orphan drug products to patients with rare diseases. Under the guidance of the mentor, the participant will research and learn to develop a database regarding orphan drug products from multiple data resources. The participant will also learn to perform quantitative analysis to disclose generic availability for orphan drug products. The participant will utilize advanced modeling approaches to identify critical factors that impact the generic availability.
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 four months, 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.