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

FDA Fellowship - Assessing Rare Safety Signals in Psychiatric Clinical Trials

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 6 hours ago

therapeutics and generic drugs. These efforts cover more than just medicines. Research Project: Safety assessments for medications intended to treat psychiatric conditions present unique challenges in signal

FDA Quantitative Systems Pharmacology Modeling for Fetal Cardiac Safety Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 6 hours ago

turn this project will advance safety and understanding of potential toxicity of FDA-regulated products in the perinatal population. Learning Objectives: Under the guidance of the mentor, you will gain

FDA Fellowship - Integrated Clinical Trial Database Development for Drug Safety

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 6 hours ago

database from randomized and controlled clinical trials for drugs intended to treat diabetes, overweight, and lipid disorders, enhancing FDA's safety signal detection capabilities. You will collaborate with

FDA Nonclinical Data and Drug Safety Regulatory Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 6 hours ago

: This research project will examine the use of nonclinical in vitro studies to evaluate drug safety and support regulatory decision-making. Research involves using state-of-the-art automated patch clamp

FDA Developmental Safety Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 6 hours ago

-the-counter and prescription drugs, including biological therapeutics and generic drugs. These efforts cover more than just medicines. Research Project: Pediatric developmental safety studies in drug

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 6 hours 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

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 | about 7 hours ago

, including Reddit, for the detection of any emerging topics on safety/adverse events. Additional project details will be determined by the FDA Office of Surveillance and Epidemiology (OSE) based on project

FDA Utilizing Artificial Intelligence to Enhance Pharmacovigilance and Inspection Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 6 hours 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 In Vitro and In Vivo Bioequivalence Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 7 hours ago

research questions involving challenging active/inactive ingredients, sophisticated formulations, and innovative dosage forms; Advance Human Subject Safety for Bioequivalence Studies - Conducting meta

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

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 7 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