FDA Fellowship in Foreign Comparator Drug Products – Manufacturing & Supply Chain Considerations
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A complete application consists of:
- An application
- Transcripts – Click here for detailed information about acceptable transcripts
- A current resume/CV, including academic history, employment history, relevant experiences, and publication list
- One educational or professional recommendation
All documents must be in English or include an official English translation.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.
*Applications will be reviewed on a rolling-basis.
CDER Office/Lab and Location: A research opportunity is available in the Office of Bioequivalence (OB), Office of Generic Drugs (OGD), Food and Drug Administration (FDA) located in Silver Spring, Maryland. This is a collaborative research project in the Center for Drug Evaluation and Research (CDER). CDER performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This research covers more than just medicines.
Research Project: This project will analyze and interpret current global trends in drug development for generics and recognize their implications on the US market and regulatory decision-making. Along with better understanding the scientific rationale and regulatory perspectives governing the utilization of foreign comparator products in bioequivalence studies within the US.
Under the guidance of the mentor, the participant will acquire a comprehensive understanding of the global supply chain for generics, particularly focusing on injection, otic, and ophthalmic drug products. The participant will gain experience evaluating the safety and manufacturing considerations of generic drug products approved in multiple jurisdictions and identifying similarities and differences across regions. Additionally, the individual will be able to develop expertise in obtaining and analyzing publicly available formulation, safety, and manufacturing information for generic drug products; and gain understanding of the scientific rationale and regulatory perspectives governing the utilization of foreign comparator products in bioequivalence studies within the US.
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.
The qualified candidate should have received or be currently pursuing a master's or doctoral degree. The technical background should be in the area of health sciences, pharmaceutical outcomes and policy, pharmaceutical sciences, pharmacology, pharmacy, chemistry, and medical sciences.
I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)
I have read the FDA Ethics Requirements.
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