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

FDA Nonclinical Data and Drug Safety Regulatory Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 1 hour ago

electrophysiology to assess mechanisms of drug effects on cardiac and neuronal ion channels critical for safety evaluation. Additionally, the research will include advanced statistical modeling for data analysis and

FDA Postdoctoral Fellowship - Clinical Pharmacology and Immunogenicity Data Assessment

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 1 hour 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 1 hour 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 Research Fellowship: Biologic Products and the Regulatory Evaluation of Biosimilars

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 1 hour ago

products, with no clinically meaningful differences in safety, purity, or potency. Despite advances in analytical and functional characterization, establishing a robust quantitative link between analytical

FDA Computational Toxicology fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 1 hour 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 Utilizing Artificial Intelligence to Enhance Pharmacovigilance and Inspection Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 1 hour ago

intelligence-enabled opioid pharmacovigilance and inspection software application that advances drug safety surveillance by integrating real-world data and regulatory data. The new comprehensive multi-resource

FDA Fellowship - Integrated Clinical Trial Database Development for Drug Safety

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

a multidisciplinary team to develop frameworks for standardizing and combining subject-level data from hundreds of clinical trials, including over 20 completed cardiovascular outcome trials. You will

FDA Application of AI for Precision Medicine Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 1 hour ago

analyzing data within the Center for Drug Evaluation and Research (CDER) drug submission database. The project will help modernize CDER’s data analytics capabilities and support FDA’s mission to protect

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 1 hour 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 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 1 hour ago

, there are only animal data to inform the safety in pregnant and lactating women. Pregnancy safety and lactation data are collected predominantly in the post approval setting. The 2007 FDA Amendments Act gave FDA