GAITHERSBURG, Md.--(BUSINESS WIRE)--Gene Logic Inc. (NASDAQ:GLGC) announced today that it has entered into a collaboration with the United States Food and Drug Administration (FDA) to share quality control methods and metrics that may be useful in better understanding disparate genomic data sent as part of regulatory submissions. The collaboration is part of the FDA’s Critical Path Initiative, an effort to stimulate and 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 from laboratory concept to commercially approved medicines. The results of the collaboration will be released publicly as an early step towards formulating industry-wide standards for genomic data assessment. There are currently no federal or industry standards in place for assessment of the quality of genomic data submissions to the FDA.
