FDA Research Fellowship: Neurodevelopmental Assessment of Prenatal Analgesic Exposure Using Tra

How to Apply

To submit your application, scroll to the bottom of this opportunity and click APPLY
.

Required materials:

• An application
• Transcripts –  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.

Questions? Send an email to ORISE.FDA.CDER (include reference code).

3/31/2026 3:00:00 PM Eastern Time Zone

U.S. Food and Drug Administration (FDA)

FDA-CDER-

A research opportunity is available immediately with the FDA, Center for Drug Evaluation and Research (CDER), located in Jefferson, Arkansas, approximately 30 miles south of Little Rock.

The participant will join a project to assess the neurotoxicity of a drug of great interest to CDER. The resulting data may impact guidelines over the use of the drug of interest in pregnancy. The National Center for Toxicological Research (NCTR) is currently investigating the developmental neurotoxic potential of an analgesic at the request of CDER.

NCTR currently has two projects underway investigating the compound in question. One focuses on histological and molecular endpoints in the guinea pig and is ongoing, while a second study investigating histological, molecular, and behavioral endpoints in the rat has just started.

Under the guidance of a mentor, the ORISE participant will be involved in most aspects of the study including experimental design, in‑life data collection, endpoint validation and collection, data analysis, and data dissemination. The participant will regularly present and discuss findings at internal meetings that will include members of NCTR and CDER staff.

As a participant, you will learn numerous neurotoxicity assessment methods including histological and molecular imaging, molecular analysis methods including protein expression quantification, advanced behavioral assessments, and MRI techniques. Additionally, these studies will take a year of preparation in advance, so you will gain firsthand experience in preparing experiments. You will have the opportunity to present findings at internal and external meetings and be a part of manuscript preparation.

Throughout the project, you will gain expertise with many laboratory methods related to the analysis of neurotoxicity and the assessment of developmental endpoints in rodents. Additionally, you will learn how to assess neurotoxicity within the lab and determine if findings are of regulatory relevance.

What makes this a unique training experience is that you will gain firsthand experience performing a regulatory‑style study and have access to regulators. "Regulatory‑style" toxicity assessments differ from "academic" toxicity studies. The perspective of the regulator is rarely expressed outside of the regulatory institution. This opportunity for research experience and regulatory exposure is rare. As an ORISE participant involved in this project, you will gain an excellent understanding of how to generate regulatory‑style toxicological data and how to evaluate the generated data in a regulatory context.

Upon completion, you will have skills to pursue a career in basic neurotoxicity research, regulatory toxicity research, or in regulatory assessments.

John Talpos (john.talpos.gov) and Timothy Flanigan (timothy.flanigan.gov). If you have questions about the nature of the research, please contact the mentors.

• Anticipated appointment start date:
  May 2026 (flexible)
• Appointment length:
  Initially one year, may be renewed upon recommendation of FDA and contingent on availability of funds
• Level of participation:
  Full time
• Participant stipend:
  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…