Gene Logic is working with the FDA to help the agency better understand genomic data sent as part of regulatory submissions. The company will share quality control (QC) methods and metrics that the FDA may use during evaluation.
Currently there are no federal or industry standards in place for microarray data submissions.
The results, which will be released publicly, will be an initial step toward formulating industry-wide criteria for genomic data assessment.
The collaboration is part of the FDA's Critical Path Initiative, which is intended to improve the predictability and efficiency of drug development.