'We Are All in This Together:' Regulatory Professionals and the Future of Personalized Medicine

| 01 March 2011

In her February 2010 speech to the Personalized Medicine Coalition, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg set forward a prospective view of the regulatory conditions necessary to support the advancement of personalized medicine. "[W]e need to develop a consistent, comprehensive and integrated approach to the evaluation and regulation of medical products which separately, and in combination, comprise the practice of personalized medicine." After expounding upon the changes the current system must undergo to move toward this new approach, the commissioner issued this admonition: "I want to underscore the point that we are all in this together."1


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