35 linked-data-"https:" "https:" "https:" uni jobs at Center for Drug Evaluation and Research (CDER)

FDA Pediatric Extrapolation: Analysis Using FDA Clinical Trial Data

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 11 days ago

efficacy in children often based on data in adults based on assumptions or evidence of disease and response similarity between adults and children. The critical need to systematically assess extrapolation

FDA Artificial Intelligence and Open-Source Data for Advanced Quality Surveillance

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 11 days ago

generic drugs. This effort covers more than just medicines. Research Project: With the development of Artificial Intelligence and Open-Source Data for Advanced Quality Surveillance, the Office of Quality

FDA Enhancing the Review of Mediation Analyses: Developing a Regulatory Checklist and AI Support Tool

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 28 days ago

—an international consensus guideline that promotes transparency and reproducibility in mediation analyses (JAMA 2021;326(11):1045–1056; https://jamanetwork.com/journals/jama/fullarticle/2784353 )—as the

FDA Opportunity - Web-based Visualization Tool for NDA/BLA Submission Info

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 11 days ago

information to enable real-time summarization and visualization of submission data for FDA reviewers. Learning Objectives: You will receive comprehensive training in eCTD submission processes, NDA/BLA

FDA Research Opportunity - Quality Knowledge Management Throughout the Drug Product Lifecycle

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 4 hours ago

related to pharmaceutical quality, lifecycle management of drug products, and data analytics and modeling to support regulatory decision making. You will acquire the above mentioned through direct

FDA Bayesian Inference for Safety Signal Detection

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 11 days ago

or adverse events in rare disease populations due to limited data and low event frequencies. Frequentist methods often lack sufficient power to detect safety signals in these scenarios. Bayesian methods offer

FDA Research Opportunity - Analysis of Patient Diversity and Ineligibility Rates in Cancer Pivotal Clinical Trials

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 11 days ago

prevalence data, and evaluating ineligibility rates by race and ethnicity. The project will examine at least 20 drugs/trials and may stratify analyses by U.S. versus non-U.S. sites. Learning Objectives: You

Comparing Neonatal Adverse Drug Events from the Literature with FDA Labels

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 11 days ago

the Pediatric Research Equity Act, exceedingly few drug development programs include neonates. As a result, a relatively small number of drugs have the safety and efficacy data necessary to support

FDA Bayesian Statistical Approaches to Address the Unique Challenges of Rare Disease Drug Development

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 11 days ago

disease drug development within FDA's regulatory framework. You and mentors will research Bayesian dynamic borrowing methods for augmenting small sample sizes through incorporation of historical data

FDA Advanced Evaluation of Postmarket Product Quality Reports

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 11 days ago

market report management database and tools. The focus of the project will be to conduct data analysis and research different methodologies to identify and compile clusters and/or trends for potential