The FDA's attitude will be crucial in the willingness of drugmakers to adopt personalized medicine and its wider application, writes Henry I. Miller, the founding director of the FDA Office of Biotechnology. Huge development costs could be imposed by the regulatory demand for extensive clinical trials to prove new drugs' safety as well as the need to develop biomarkers to go with these drugs, he writes. Furthermore, the diminished revenue potential may in the end become unsustainable for drugmakers, he writes.

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