FDA Intrauterine Drug Delivery Systems Fellowship
*Applications will be reviewed on a rolling-basis.
A research opportunity is currently available with the Office of the Commissioner (OC) Office of Women's Health (OWH), U.S. Food and Drug Administration (FDA). The project will be located at the Office of Pharmaceutical Quality at the Center for Drug Evaluation and Research (CDER) in Silver Spring, Maryland.
This project will explore the burden of clinical studies related to intrauterine systems (IUSs). Levonorgestrel (LNG) intrauterine systems (IUSs) is an effective and reversible long-term contraception option and its popularity has grown considerably in the past few decades. Currently, there are four FDA approved long-acting LNG IUSs on the U.S. market. There is a need to promote product development and regulatory approval of generic LNG IUSs to increase the affordability of the long-acting IUSs. Yet, the long in vivo application duration and complex product design present unique challenges which could hinder the development of generics. In this project, we aim to obtain mechanistic understanding on formulation design and performance of LNG-IUSs through novel in vitro drug release testing (IVRT) and advanced imaging based morphological characterization. We envision that this study will shorten the time-exhaustive procedure required to support bioequivalence, reducing both scientific and regulatory burden on approving generic LNG-IUSs.
The participant will learn about the mechanism of drug release from IUS and the method of characterization. This training will provide the participant comprehensive scientific knowledge since they will be involved with the development and optimization of IVRT method for IUS.
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.
Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.
FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency. This agreement covers such topics as the following:
- Non-employee nature of the ORISE appointment;
- Prohibition on ORISE Fellows performing inherently governmental functions;
- Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
- The fact that research materials and laboratory notebooks are the property of the FDA;
- ORISE fellow’s obligation to protect and not to further disclose or use non-public information.
If you have questions, send an email to ORISE.FDA.OC.other@orau.org.