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

FDA Serum Creatinine Elevation Due to Renal Transporter Inhibition

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 10 hours ago

project and under the guidance of the mentor, you will contribute with: Collecting comprehensive data on oncology drugs known to inhibit renal transporters (particularly OCT2, MATE1, and MATE2-K), including

FDA Dosing of Cancer Drugs in Obesity

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 10 hours ago

-making regarding appropriate dosing, clinical trial design, and labeling of oncology drugs for patients with obesity. During the appointment you will: Engage in comprehensive data analysis of oncology

FDA Over the Counter Drug Monograph Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 10 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

FDA Computational Toxicology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 10 hours 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 Fellowship - Evaluation of Non-Inferiority Margin for Drug Products

Center for Drug Evaluation and Research (CDER) | United States | 3 days ago

macular edema (DME), with potential expansion to other retinal indications, through network meta-analysis and patient matching methodologies applied to historical and recent clinical data. The participant

FDA Evaluating Consumer Study Regulatory Review Approaches for Applications with Novel Digital Technologies

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 10 hours ago

. Mitigations (rules that may change an incorrect response in a study to a correct response) and participant verbatim information requiring qualitative analysis, complicate consumer study review, making review

FDA Over the Counter (OTC) Drug Product Regulatory Analysis of Antigingivitis/Antiplaque Monograph

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 10 hours ago

methods informs OTC drug monographs and labeling. Scientific writing and data analysis/synthesis: Developing a peer-reviewed manuscript for a regulatory science journal with data tables and visual

FDA In Vitro and In Vivo Bioequivalence Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 10 hours ago

foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page  of the program website for information about the valid immigration statuses

FDA Determination of Qualification Limits for Peptide-related Impurities of Follow-on Products to Inform Guidance

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 10 hours ago

website for information about the valid immigration statuses that are acceptable for program participation. This program, administered by ORAU through its contract with the U.S. Department of Energy to

FDA Research Fellowship: Neurodevelopmental Assessment of Prenatal Analgesic Exposure Using Translational Models

Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | about 10 hours ago

of great interest to CDER. The resulting data may impact guidelines over the use of a drug of interest in pregnancy. The National Center for Toxicological Research (NCTR) is currently investigating