*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 Generic Drugs/ Office of Bioequivalence (OB) in Silver Spring, Maryland.
The Office of Bioequivalence relies upon a multitude of scientific databases to assess the acceptability of a generic drug application. The current process requires reviewers to individually search the databases and synthesize the information. Due to the challenges of processing disparate sources of information, the assessment of a review can vary among reviewers. This in turn can lead to additional review cycles, unnecessary deficiencies, and increased number of meetings, and can limit the ability to use past experience to make a decision. The aim of the project is to develop a "one stop shop" database that will unify the different databases.
Under the guidance of the mentor, the participant will learn the concepts and principles of bioequivalence, pharmacokinetics, and pharmacodynamics. The participant will also learn about making a knowledge management database which enables an assessment of an application using all available knowledge. The participant will learn about the regulations and guidance underlying the review and assessment of generic drug applications.
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.