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FDA in Personalized Medicine

In a report published this week, the US Food and Drug Administration delineates its role in — and the challenges it faces for — implementing personalized medicine.

"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," said Margaret Hamburg, the FDA commissioner, at a press briefing Monday according to MedPage Today.

The report notes that FDA has altered some of its regulatory processes to better fit with how personalized medicines and their related diagnostics need to be evaluated. For example, it says that the agency has moved three regulatory programs affecting in vitro diagnostics — premarket review, compliance, and post-market safety — into a single location, which should "[ensure] that all diagnostic device activity related to these products would spring from a common consolidated technical and regulatory base."

Whole-genome sequencing poses its own set of regulatory challenges, FDA notes in the report. It says that determining the analytical and clinical validity for each variant, and especially rare variants, will be near impossible. Instead, the agency says that it is looking into evaluating sequencing tests based on the analytical performance of the platform. And instead of examining each variant, it is considering gauging performance based on a representative set of markers.

"Next-generation sequencing is a tool that's coming very rapidly into the clinic. It's going to change the way we treat people, more so in oncology than in other areas in the beginning," said Elizabeth Mansfield, director of personalized medicine at FDA's Center for Devices and Radiological Health, according to MedPage Today. "FDA is working really hard through our personalized medicine programs and with intercenter collaborations to be able to address this technology to be sure patients have access to safe and effective diagnostics that we hope will lead to safe and effective therapies."