33 web-developer-"https:" "https:" "https:" uni jobs at Center for Drug Evaluation and Research (CDER)

FDA Drug Product Quality Assessment

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | 14 days ago

. Offices within OPQ are collaborating to develop and validate a universal gas chromatography-mass spectrometry (GC-MS) method to assess drug products for benzene contamination. This project aims to develop a

FDA Clinical Pharmacology of Novel Modality Biological Products

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 14 days ago

to evaluate innovative study designs for assessing novel modality clinical pharmacology and research regulatory precedents and contribute to guidance document development for emerging therapeutic modalities

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

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 14 days ago

development for inflammatory bowel disease (IBD). Since the approval of infliximab for Crohn’s disease in 1998, multiple advanced therapies—including ten biologics and four small molecules—have been approved

FDA Dosage Optimization of Antibody-Drug Conjugates

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 14 days ago

products and development programs. Participate in discussions with the Division of Cancer Pharmacology (DCP) leadership, clinical pharmacology reviewers, and team leads regarding how the results

FDA Dosing of Cancer Drugs in Obesity

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 14 days ago

to the development of evidence-based guidance for oncology drug dosing in patients with obesity. Gain hands-on experience with data analysis/platforms and knowledge of regulatory science and oncology drug development

FDA Advanced Evaluation of Postmarket Product Quality Reports

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 14 days ago

product quality signals. During the appointment, you will help explore important parameters in cluster and/or trend identification to help with the development of an algorithm that can be used for signal

FDA Characterization of Topical Spray Drug Products

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | 14 days ago

drugs, including biological therapeutics and generic drugs. This effort covers more than just medicines. Under the guidance of the mentor, the participant will develop aerosol/particle analytical methods

FDA Risk Assessment of Contaminants for Supply Chain Risks

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 14 days ago

impurities and contaminants based on high-risk excipient lists from multiple sources.  This research will include developing a curated high-risk excipient list based on standard definitions of risk (e.g., ICH

FDA Regulatory Analysis of Dose-Finding and Optimization Approaches in Targeted Oncology Therapeutics

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 14 days ago

clinical data from multiple sources within FDA's information systems. You will gain regulatory science experience and policy development insight that supports advancement in clinical pharmacology, drug

FDA Pediatric Extrapolation: Analysis Using FDA Clinical Trial Data

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 14 days ago

assumptions is well recognized in pediatric drug development. The FDA has access to data from approximately 1,200 pediatric clinical trials of which data from 600 trials spanning over 300 pediatric development