The Division of Applied Regulatory Science (DARS) was established in September 2013 to provide the Center for Drug Evaluation and Research with expanded laboratory and computational research capabilities. DARS’ mission is to develop laboratory data and assays, biomarkers, data-based tools, best practices, and approaches to address immediate and emerging regulatory science issues that impact the development, evaluation, and utilization of new therapeutic products.<br/><br/>DARS responds to a wide range of reviewer questions and emerging regulatory science challenges by: developing a portfolio of laboratory and computational research projects; providing computational toxicology consults on drug impurities, metabolites, and packaging leachables; and providing expert consults addressing different pharmacology, toxicology and post market product safety issues on topics as varied as generic bioequivalence, adverse event mechanisms, data standards, drug interactions, and drug metabolism. DARS has also been active as subject matter experts in reviewing submissions for internal FDA funding programs, research protocols from other FDA Centers, and proposals received under the FDA’s Broad Agency Announcement Program to support regulatory science and innovation. DARS generates benchmark data on adverse event mechanisms to improve FDA’s understanding of drug safety and patient response. The Division has expertise in genomics, cell biology, pharmacology, pharmacokinetics, drug metabolism, toxicology, clinical pharmacology, medical toxicology, veterinary science, and computer modeling. DARS is actively engaged in laboratory research across multiple issues, drug classes and therapeutic areas.<br/><br/>This presentation will provide an overview of DARS, including examples of pharmacology and toxicology research projects demonstrating regulatory impact.

Introduction to division of applied regulatory science: Research to evaluate and enhance drug safety

254th National Meeting (2017)

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