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Nov 25, 2013
 |  BioCentury  |  Regulation

Hamburg's call for change

FDA's Hamburg says agency must change to adapt to new science

In a wide-ranging interview with BioCentury This Week television that touched on new models for personalized medicine, proposals to create a special medical use pathway, and new drug compounding legislation, FDA Commissioner Margaret Hamburg argued the agency and industry both must adapt to the rapidly changing scientific landscape.

FDA's Nov. 19 approval of the MiSeqDx genome sequencing system from Illumina Inc. for broad clinical use exemplifies both the pace of scientific change and FDA's attempt to respond to it.

"We are at a critical point in the road, where science and technology is evolving to a point where we have to think about and use this important genetic information in new ways," Hamburg told BioCentury. "And certainly, it means we have to rethink our paradigm for how we review diagnostics and how we link diagnostics to the ultimate treatment of disease" (see BioCentury This Week, Nov. 24).

Prior to the Illumina approval, senior FDA officials said they view next-generation sequencing technology as a tool that will make the development and especially the clinical use of targeted or personalized medicines more efficient (see BioCentury, Nov. 4).

The use of rapid next-generation sequencing technology doesn't mean the one-drug, one-diagnostic model of personalized medicine is over, "but it can't be our only...

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