FDA Basic Video: Alberto Gutierrez Interviewed on Diagnostic Tests and Personalized Medicine (video)
What role does FDA play in such areas as personalized medicine, diagnostic testing, cell phones, medical devices, and radiation-emitting products?
Alberto Gutierrez is director of the Office of In Vitro Diagnostics in the Center for Devices and Radiological Health. He says that new genetic tests together with other diagnostic tools are making it increasingly possible to better target drugs "so that we’ll get the right drug to the right person at the right time." Says Gutierrez: "Previously, drugs were developed... and tested in a whole population. Now drugs are being developed for specific persons of a specific people or to be given to people to be able to prevent—so that we don’t actually give the drug to somebody who’s going to have an adverse event..." One of the challenges, he adds, is how we regulate this new world of personalized medicine. Learn More About Medical Devices...
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