Gene Logic has inked an agreement with the FDA to share quality control methods and metrics that may help the agency understand disparate genomic data sent as part of regulatory submissions. The collaboration is part of the FDA's Critical Path Initiative, the FDA's effort to help the industry choose the right drug candidates early on and move them quickly and successfully through the approval process. The results of the Gene Logic/FDA collaboration will be released publicly as a first step toward formulating industry-wide standards for genomic data assessment--there are currently no standards in place.
Things have been busy at Gene Logic lately, as the company has signed deals with several large drug developers to take a second look at their de-prioritized drug candidate. This pact will be a nice boost for the company's less-than-successful genomics division.
- see Gene Logic's release
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