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

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

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 13 days 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 | 13 days 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 Fellowship - Assessing Rare Safety Signals in Psychiatric Clinical Trials

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 13 days ago

-market surveillance systems suffer from underreporting bias, confounding by indication, and unclear temporal relationships. Meta-analyses based on pooled study-level or subject-level clinical data play a

FDA Drug Product Quality Assessment

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | 13 days ago

for industry guidance, and the quality assessment of drug products for benzene contamination. You will conduct data interpretation and evaluation, gain regulatory process knowledge, conduct experiments, and

FDA Fellowship - Large language Models in Post-Market Surveillance of Drugs Using Social Media

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 13 days ago

needs and participant interest. This research project is supported under the  21st Century Cures Act (2016) Section 3022 (Drug Safety) to evaluate real-world evidence data on drug’s use or risks from

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

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 13 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 Fellowship - AI to Evaluate Maximum Daily Dose for Topical Drugs

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 13 days ago

language model-powered AI tool for use in extracting and summarizing information from application files and labeling and develop new generative and agentic AI models for testing in the evaluation of topical

FDA Modeling and Simulation Fellowships

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 13 days 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 High-resolution Analytics Fellowship for Oligonucleotide Therapeutics

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | 13 days 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 Over the Counter (OTC) Drug Product Regulatory Analysis of Microbial Risks: Case Study on Ophthalmic Eye Drops

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 13 days ago

. The research will analyze published literature, post-marketing data, and simulated-use studies to evaluate contamination pathways, packaging integrity, consumer misuse patterns, and labeling practices. You will