FDA Top Officials Discuss Ongoing Efforts to Bring Agency Into Genomics Era
(Genomeweb) - From the outside, it may seem that while the US Food and Drug Administration often talks about the promise of personalized medicine, the agency is slow to act when it comes to issuing regulatory policies critical to advancing the discipline. However, two FDA officials last week tried to dispel that notion by highlighting the agency's ongoing efforts to personalize healthcare by improving internal expertise in pharmacogenetics, increasing its focus on regulatory sceince, and launching a new group to coordinate its drug and diagnostics divisionsÂ’ application reviews for Rx/Dx combination products.
Issam Zineh, associate director for genomics at the Office of Clinical Pharmacology, and Elizabeth Mansfield, director of personalized medicine at the Office of In Vitro Diagnostic Evaluation, spoke at a symposium this week on the agency's personalized medicine efforts at FDA's Center for Drug Evaluation and Research and the Center for Devices and Radiological Health, respectively.
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