*Applications will be reviewed on a rolling basis This fellowship, administrated through the Oak Ridge Institute for Science and Education (ORISE), offers a one-year opportunity for post-master’s degree or doctoral candidates. The fellow will participate on a project to develop tools to support the regulatory evaluation of deep learning-assisted medical image formation (e.g., unrolled methods, deep-imaging priors) and post-processing techniques (e.g., denoising, super-resolution). The research will encompass implementing modern deep learning algorithms and image quality assessment using bench testing data, …
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*Applications will be reviewed on a rolling basis This project is in the Office of New Drugs (OND), Immediate Office (IO). This project will conduct regulatory research on drug induced liver injury (DILI) mechanisms using new approach methodologies (NAMs) such as micro physiological systems (MPS). We anticipate conducting experiments using multiple MPS platforms from different manufacturers and evaluating multiple drugs that have been shown to cause DILI via different mechanisms. This type of cross platform, cross laboratory research using the same …
*Applications will be reviewed on a rolling-basis. Anticipated Start Date in June 2024. The project involves development and validation of a method for chromium speciation analysis in foods and dietary supplements. The candidate will learn how to evaluate existing methods for extraction and quantification of chromium species in a regulatory setting and develop methods that can meet the objectives of this study. The participant will receive hands-on training on the use of various sample preparation and analytical techniques including microwave-assisted …
*Applications will be reviewed on a rolling-basis. The project is located in the Office of Testing and Research (OTR), Office of Pharmaceutical Quality (OPQ). The goal of the project is to determine the comparability of biosimilars and assess the impact of advanced manufacturing technologies on quality of ensuing products. Under the guidance of the mentor, the participant will receive training in the manufacturing of biologics and complex drug products, lyophilization, product quality analysis and use of AI for laboratory data analysis. The Center …
CDER Office/Lab and Location: A research opportunity is available in the Office of Oncologic Diseases (OOD), Office of New Drugs (OND), within the Food and Drug Administration (FDA) located in Silver Spring, Maryland. 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 FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This research covers more …
The U.S. Federal Bureau of Investigation (FBI) Critical Incident Response Group (CIRG) consists of a cadre of special agents and professional support personnel who provide expertise in crisis management, hostage rescue, surveillance and aviation, hazardous devices mitigation, crisis negotiations, behavioral analysis, and tactical operations. What will I be doing? As a research fellow with the Critical Incident Response Group (CIRG) Visiting Scientist Program (VSP), you will enhance your professional development and increase your research capabilities by participating in research initiatives under the …