FDA Pediatric Extrapolation: Analysis Using FDA Clinical Trial Data U.S. Food and Drug Administration (FDA) in United States

This research opportunity is based in the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER), within the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine and the Division of Pediatrics and Maternal Health in Silver Spring, Maryland. The project is part of FDA’s broader effort to ensure safe and effective drugs for children and adults, using the agency’s access to extensive pediatric clinical trial data. The selected participant will work on ...

This research opportunity at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) is based in White Oak, Maryland and focuses on improving dose selection for products used in inflammatory bowel disease (IBD). The project sits within FDA’s regulatory science environment, where the goal is to support safer and more effective pediatric therapeutics through better evidence on dosing. The fellow will examine how dose-selection strategies have been used in clinic...

This research opportunity at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) focuses on how dose selection and optimization are being used in targeted oncology therapeutics , including drugs such as tyrosine kinase inhibitors. The project is set within the FDA’s regulatory science environment in White Oak, Maryland, where CDER evaluates the safety and effectiveness of drugs used in the United States. The participant will work on a project that collects...

This research opportunity is based in the Office of Immunology and Inflammation , Office of New Drugs , Center for Drug Evaluation and Research at the U.S. Food and Drug Administration in Silver Spring, Maryland. The project focuses on the statistical evaluation of TD50 and benchmark dose approaches for deriving acceptable intakes of carcinogenic impurities. The appointed participant will use simulation studies to examine how these approaches perform and to help build a stronger statistical basi...

This research opportunity is offered by the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), in Silver Spring, Maryland. The project is centered on pharmacodynamic biomarkers and their growing role in drug development and regulatory decision-making. The selected participant will examine how pharmacodynamic biomarkers are being used in the evaluation of new drugs, including target engagement, dose selection, patient selection, safety monitoring, exposure-re...