45 web-development-"https:"-"https:"-"https:" Fellowship positions at Center for Drug Evaluation and Research (CDER)

FDA Computational Biology and Pharmacology Fellowship

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

validation of human-based in vitro and computational methods submitted to FDA for regulatory use. The developed models will be used to predict various toxicity endpoints and drug exposure to help provide

FDA Pharmacy Compounding Regulatory Analysis Fellowship

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

drug compounding, including, but not limited to specific bulk drug substances that are used in compounding, advancing FDA's development of the Bulk Lists of substances that can be used in human

FDA Fellowship - AI to Evaluate Maximum Daily Dose for Topical Drugs

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 13 hours 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 Evaluating Time-Course of Anti-Drug Antibodies for Therapeutic Proteins Fellowship

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

, additional research is needed to establish its utility for quantitatively characterizing ADA time-course profiles compared to traditional tiered approaches. In our previous research, we developed a

FDA Fellowship - Optimization of Drug-induced Liver Injury Analysis Methods

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

methodologies, statistical analysis of rare adverse events, and understanding of health disparities in clinical research. Learning Objectives: You will develop skills in safety signal detection, learn to identify

FDA Over the Counter Drug Monograph Research Fellowship

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

, or sunscreens to support monograph development and updates. Participants will engage in learning opportunities through mentored training sessions focused on OTC drug monograph research methodologies and

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 | about 13 hours ago

components for each ORISE fellow (computational, complex in vitro modeling - CiVM and bioanalytical). Computational: The participant will assist in the development of quantitative systems pharmacology models

FDA Quantitative Systems Pharmacology Modeling for Fetal Cardiac Safety Fellowship

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

. Serotonin promotes the growth of fetal heart cells while abnormal or blocked serotonin levels can change heart development. Understanding the mechanisms responsible for this association is crucial

FDA Computational Toxicology fellowship

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

reviewers' conclusions in queryable databases; however, reviewer conclusions are only successfully recorded for a subset of the toxicology study data submitted. These databases will be utilized to train

FDA Regulatory Science Research Project Related to Safety of Medications in Pregnancy in the Post Approval Setting

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

of pregnancy and lactation postmarketing requirement studies. Pregnant and lactating women have historically been excluded from drug development trials. Therefore, at the time of new drug/biologic approval