What are the responsibilities and job description for the FDA Fellowship - Orange Book NDA and ANDA Parenteral Drug Product Project position at Zintellect?
*Applications will be reviewed on a rolling-basis.
FDA Office and Location: A research opportunity is available in the Office of Generic Drugs (OGD), Office of Generic Drug Policy (OGDP), Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) located in Silver Spring, Maryland. Virtual attendance allowed on certain days.
The Center for Drug Evaluation and Research (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 U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. These efforts cover more than just medicines.
Research Project: This project will examine Orange Book line listing practices, as well as NDA and ANDA approval letters and labeling, to ensure that correct product listing information is captured. It will also involve researching reference listed drug (RLD), reference standard (RS), therapeutic equivalence (TE) codes, and approval date information to support listings on the Orange Book website. Additionally, the project will provide information to facilitate responses to controlled correspondences and Citizen's Petition inquiries, and to meet other programmatic objectives.
Learning Objectives: Under the guidance of the mentor, you will gain an understanding of fundamental drug product listing processes of the Orange Book publication, which will also provide you with a high-level awareness of regulatory reviews related to FDA approved medications.
Mentor: The mentor for this opportunity is Timothy Kim (T.KIM@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.
Anticipated Appointment Start Date: 2026. Start date is flexible and will depend on a variety of factors.
Appointment Length: The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.
Level of Participation: The appointment is full time.
Participant Stipend: The participant will receive a monthly stipend commensurate with educational level and experience.
Citizenship Requirements: This opportunity is available to U.S. citizens only.
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 participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. 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.