Will FDA s PGx Draft Guide Encourage Pharma to Invest In New Technologies? | GenomeWeb

Fulfilling a promise it made to industry this spring, the US Food and Drug Administration this week released for public comment its much-anticipated draft guidance on the submission of certain pharmacogenomics data.

The draft, which the FDA’s Center for Drug Evaluation and Research originally said would be ready for public comment over the summer, is designed to generally instruct industry about when and how pharmacogenomics data should be submitted with certain new drug applications, investigational new drug applications, and biological license applications.

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