15 data-"https:"-"https:"-"https:"-"https:"-"https:" Fellowship positions at Center for Drug Evaluation and Research (CDER)

FDA Postdoctoral Fellowship - Clinical Pharmacology and Immunogenicity Data Assessment

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

collaborate with FDA scientists to compile immunogenicity assessment data from multiple regulatory sources, including Biologics License Applications (BLAs), validation reports, and clinical pharmacology review

FDA Computational Biology and Pharmacology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

Office of New Drugs (OND) are creating new and updating existing toxicity databases based on available nonclinical animal data (and available clinical data where applicable) that could be used in

FDA Research Fellowship: Biologic Products and the Regulatory Evaluation of Biosimilars

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

or limited multivariate analysis. However, the increasing dimensionality and complexity of analytical data demand AI/ML-based frameworks capable of learning nonlinear, high-dimensional relationships between

FDA Over the Counter Drug Monograph Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

: Conduct literature searches on specific monograph drug active ingredients using regulatory science databases and evaluate scientific evidence supporting safety and effectiveness determinations. Data

FDA Computational Toxicology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

(QSAR) models. The selected participant will learn to harvest and interpret toxicology data, develop and apply QSAR models, and communicate research results to both internal and external stakeholders

FDA Fellowship - Evaluation of Non-Inferiority Margin for Drug Products

Center for Drug Evaluation and Research (CDER) | United States | 2 days ago

macular edema (DME), with potential expansion to other retinal indications, through network meta-analysis and patient matching methodologies applied to historical and recent clinical data. The participant

FDA Research Fellowship: Neurodevelopmental Assessment of Prenatal Analgesic Exposure Using Translational Models

Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | 2 days ago

of great interest to CDER. The resulting data may impact guidelines over the use of a drug of interest in pregnancy. The National Center for Toxicological Research (NCTR) is currently investigating

FDA Fellowship - In Silico and In Vitro Approaches to Inform Polypharmacy and Patient Effects on Opioid Overdose

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 2 days ago

and become efficient in using various computing languages, such as R, C, and Python, to develop mechanistic models to simulate human pharmacology and utilize High Performance Computing for data analysis

FDA Pediatric Drug Development Programs for Drug-Device Combination Products Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

pediatric drug development of these products. The selected fellow will be involved in the following activities related to the research project: collecting data from public and proprietary sources, analyzing

FDA Fellowship - Endpoint Strategy Selection and Statistical Analysis Plan for Non-Malignant Hematologic Disease

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 22 hours ago

under realistic data-generating scenarios (endpoint correlation, effect assumptions, alpha requirements), compare study power and other metrics (e.g., probability that endpoints are individually