26 data-"https:"-"https:"-"https:"-"https:"-"https:"-"https:"-"UNIV" 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 | about 8 hours 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 Toxicology fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours ago

, including biological therapeutics and generic drugs. This effort covers more than just medicines. Research Project: CDER has recently begun storing both electronic toxicology study data and nonclinical

FDA Evaluating Time-Course of Anti-Drug Antibodies for Therapeutic Proteins Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours ago

mathematical ADA model to provide quantitative immunogenicity assessment for therapeutic proteins. This model was constructed using antibody titer data from subjects across 10 clinical trials, with ADA time

FDA Large Language Models (LLM) for Case Definition Classification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours ago

 contribute to projects that are mandated under the 21st Century Cures Act (2016) Section 3022 (Drug Safety) to evaluate real-world evidence data on drug’s use or risks from sources other than clinical trials

FDA Pharmacy Compounding Regulatory Analysis Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours ago

compounding. Learning Objectives: Under the guidance of the mentor, you will gain skills and confidence in making scientific presentations; learn how to collect and compile clinical information; and learn

FDA Computational Biology and Pharmacology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours 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 High-resolution Analytics Fellowship for Oligonucleotide Therapeutics

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 8 hours ago

. Additionally, you will participate in data evaluation and documentation, collaborating with their mentor on publications, presentations, or reports to learn effective communication of regulatory science to both

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

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours 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 Modeling and Simulation Fellowships

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours ago

evaluation, active ingredient sameness demonstration, and post marketing safety surveillance. This Division coordinates modeling, simulation, data analysis and data mining, and establishes the scientific

FDA Over the Counter Drug Monograph Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours ago

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