32 data-"https:" "https:" "https:" "https:" "https:" "https:" "https:" "Univ" uni jobs at Center for Drug Evaluation and Research (CDER) in United States

FDA Serum Creatinine Elevation Due to Renal Transporter Inhibition

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 3 days 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 | 3 days 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 Development of Analytical Methods to Assess Nitrosamine Impurities in Over-the-Counter (OTC) Monograph Drug Products

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | 3 days 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 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 | 3 days 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 Development of a Cell-based Potency Assay for Reproductive Hormone Therapies

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 3 days ago

. citizens, Lawful Permanent Residents (LPR), and 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

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 | 3 days 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 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 | 3 days 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 Developing Novel Technologies for Identification/Characterization of Glycans on Glycoproteins

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 3 days ago

, Lawful Permanent Residents (LPR), and 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

FDA Clinical Pharmacology of Novel Modality Biological Products

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 3 days ago

, data analysis, and regulatory submission evaluations to identify knowledge gaps and establish best practices for assessment. You will analyze clinical trial datasets to characterize dose-response

FDA Research Opportunity - Dose Selection of Products for Inflammatory Bowel Disease

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 3 days ago

dose selection based on adult data and patient-specific factors. Specifically, the fellow will: Survey clinical development programs for IBD products, focusing on dose-selection strategies for adults and