The Division of Applied Regulatory Science (DARS) is located within FDA’s Office of Clinical Pharmacology and tackles emerging regulatory questions and develops and implements new regulatory review tools and approaches. FDA scientists rapidly form interdisciplinary teams of pharmacologists, biologists, chemists, computational scientists, and clinicians to respond to challenging regulatory questions for specific review issues and for longer-range projects requiring the development of predictive models, tools, and biomarkers to speed the development and regulatory evaluation of safe and effective drugs.
To move new science into the CDER review process and close the gap between scientific innovation and product review.
What we do
Mission-critical applied research to develop and evaluate novel tools, standards, and approaches to assess the safety, efficacy, quality, and performance of CDER regulated products.
Expert regulatory review consultations for mechanistic safety evaluations (determining the reasons why side effects happen) combining critical review of existing knowledge, computational analyses, in vitro (cellular models) and in vivo (animal models) laboratory studies, clinical pharmacology/experimental medicine studies, and translational analyses (translating research into practice) of preclinical and clinical studies and post-market data.
The diversity of expertise, research domains, and mission demands create a truly:
Unique Translational Regulatory Science Environment