FDA Generic Drugs Research Fellowship
*Applications will be reviewed on a rolling-basis.
Four research opportunities are available in the Office of Generic Drugs/Office of Research and Standards, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
This project in The Office of Generic Drugs/Office of Research and Standards will address scientific questions and issues that arise during generic drug application review. The goal of this project is to develop and improve methods for comparing products to facilitate the development and review of generic drugs; insight into new methods and technologies that may be used for drug development and application review. This may translate into eventual revision and drafting of new guidance, establishment of new research projects and input into regulatory submission reviews.
Under the guidance of a mentor, the participant will be trained on conducting searches of regulatory submissions to find information regarding drug product formulation, bioequivalence data, and communications to industry to understand a product's approval/review history and in vitro/in vivo drug performance. The participant will also conduct research on novel methods, technologies, databases/tools for improved characterization of a drug product, improved understanding of a drug product's performance, or improved databases/tracking tools for research. This training will prepare the participant for a successful career transition into regulatory science research - training that cannot be obtained elsewhere.
Qualifications
The qualified candidate should be currently pursuing or have received a bachelor's, master's or doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2020-0514) in your email.