FDA defines regulatory science as "the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products." Regulatory science encompasses clinical trial design, quantitative safety assessment, product quality evaluation, quality by design, data mining, pre-clinical toxicology, biomarker development, quantitative sciences including exposure-response assessments, regulatory role of novel technologies, regulatory informatics, data management, and communication of regulatory decisions. These are not traditional topics fully addressed in the current academic curriculum. In support of our public health mission, there is a need for CDER to play a lead role in cultivating future regulatory science professionals and improve the understanding of the interrelationships of these complex scientific areas.
The objective of the project is to develop training materials to introduce students to challenges in drug development and regulatory decision making. Under the guidance of a CDER mentor, the fellow will identify and compile existing CDER content and help assess the appropriateness of training materials for different audiences. It is the intent that these training materials will be made widely available to the academic community for incorporation into their regulatory science curricula.
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 the recommendation of FDA and contingent on the availability of funding. 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 or the program administrator, and there are no fringe benefits paid.
PhD or MSc. in biomedical or physical sciences received within the last five years.