With Final PGx Data Submission Roadmap In Place, FDA Eyes Future of Biomarkers | GenomeWeb

The US Food and Drug Administration has released its pharmacogenomic data submissions guidance -- finally. Now what?

The long-awaited guidance, along with supplementary materials, was developed to inform drug makers on how to submit pharmacogenomic data for drug discovery and development, for agency insight and edification, and, in the case of instruction on voluntarily submitting pharmacogenomics data, to allay industry concerns that the agency will not use these data to make regulatory decisions.

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