FDA Official Hints That Proteomic Data Should Play Role in Agency's Pharmacogenomic Plans | GenomeWeb

In what could become a significant step forward for proteomic researchers and tool vendors, a senior Food and Drug Administration official last week suggested that the agency's Voluntary Genomic Data Submission guidance should be updated to include proteomic and other kinds of biomarker data.

Larry Lesko, director of the Office of Clinical Pharmacology at FDA's Center for Drug Evaluation and Research, told participants at the Drug Information Association's annual meeting in Philadelphia last week that it may be time for the agency to "rethink" the VGDS program.

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