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Gene Logic, FDA Collaborate on Safety/Efficacy Data

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Gene Logic, Inc. has entered into a collaboration with the FDA regarding quality control methods and metrics for understanding disparate genomic data sent as part of regulatory submissions. The collaboration is part of the FDA’s Critical Path Initiative, an effort to facilitate the use of new scientific and technical methods—such as computer-based predictive models and biomarkers for safety and effectiveness—intended to improve the predictability and efficiency of drug development. There a...

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