SILVER SPRING, Maryland — In a detailed new report, the US Food and Drug Administration (FDA) has outlined its approach for regulating new personalized therapies and devices.
The report, Paving the Way for Personalized Medicine: FDA's Role in a New Era of Medical Product Development, outlines the fundamental ways in which the FDA has modified its traditional approaches to drug and device regulation in the new era of products that are tailored toward specific patient subtypes, rather than broad diagnostic groups.
"We're very, very excited about this report because I think it captures the broad context of what's happening in science and medicine today and the role of the FDA as we enter the era of personalized medicine, and for us, personalized medical product development," FDA commissioner Margaret A. Hamburg, MD, said in a press briefing held at the FDA headquarters Monday.
Dr. Hamburg noted that the European Union's definition of personalized medicine, "Providing the right treatment to the right patient, at the right dose at the right time," has always been medicine's goal.
"Now, with the advance of science and technology and the understanding of both the underlying mechanisms and the human response to disease, we have so many more opportunities to target therapies in exciting ways and really improve the care that we can offer and the effectiveness of treatments," she said
Starting in 1998 with the approval of trastuzumab (Herceptin, Genentech) for the treatment of HER2-positive breast cancers, the FDA has approved more than 100 drugs that contain specific information about biomarkers in the labeling. Sometimes that information is added postlicensure.
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