A research opportunity is available in the Office of Bioequivalence (OB), Office of Generic Drugs (OGD) at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), located in Silver Spring, Maryland. CDER regulates over-the- counter and prescription drugs, including biological therapeutics and generic drugs. This research covers more than just medicines.

This project will consist of becoming familiar with the regulatory framework for generic drugs, gaining understanding of recommendations followed in different jurisdictions, analyzing and summarizing the impacting factors contributing to the delay in availability of generic alternatives of topical drug products, providing insight into current trend and projecting future directions in the approval of such products, and preparing a comprehensive report of the compiled, analyzed and summarized the collected data for presentation at relevant platforms.

Under the guidance of the mentor, the participant will enhance the understanding of newly adapted bioequivalence approaches for topical drug products along with regulatory requirements by different jurisdictions. Analyzing and summarizing the impacting factors which are contributing to the delay in availability of generic topical drug products would provide direction of the current trend and future directions in the approval of these products.

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 Ethics Requirements

If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists.

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.