Emerging Technologies and their Role in Regulatory Review

EMERGING TECHNOLOGIES AND THEIR ROLE IN REGULATORY REVIEW 

Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA 

The content of this book chapter reflects the opinion of the author and should not be construed to represent any determination or policy by the US Food and Drug Administration. The mention of commercial products, their sources, or their use in connection with the material reported herein should not be construed as either an actual or implied endorsement of such products by the Department of Health and Human Services. 

Drug Discovery Toxicology From Target Assessment to Translational Biomarkers, First Edition. Edited by Yvonne Will, J. Eric McDuffie, Andrew J. Olaharski, and Brandon D. Jeffy. 

In some cases, new regulatory pathways have been developed to improve the prediction of clinical risk based on fresh 

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