Latest Developments at FDA Very Promising for Personalized Medicine

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Today HHS Secretary Kathleen Sebelius, NIH Director Francis Collins, and FDA Commissioner Margaret Hamburg hosted a joint press conference to announce an unprecedented collaboration between FDA and NIH aimed at accelerating the research to regulatory approval timeline for promising new therapies.  To assist in this effort, the initiative has established a joint leadership council that will seek to align biomedical research planning with the most pressing public health issues.  To learn more about the joint initiative, take a look at the press release from FDA or view the videocast of the joint press conference.

The collaboration between these two government agencies has great potential to advance personalized medicine, and as an article published today in MIT Technology Review indicates, advancing personalized medicine through regulatory streamlining is on the agenda for FDA.  According to the article, FDA is seeking to adjust current drug approval processes to better align with personalized medicine.  FDA expects to begin this process by developing guidelines that will enable the side-by-side approval of a drug and the companion diagnostic that will identify which population of patients is most likely to benefit from it.

We are very pleased that Dr. Hamburg, FDA Commissioner, is joining us as the keynote speaker tomorrow at the Sixth Annual State of Personalized Medicine Luncheon.  We look forward to hearing more from her on these exciting developments, and the opportunity they present to introduce a logical approval process for personalized medicine products.

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