Amid 'Chaos,' FDA's Gutierrez Offers Insights on Agency's Regulatory Stance on Molecular Tests | GenomeWeb

Originally published Feb. 12.

If Alberto Gutierrez had to describe the current state of personalized medicine regulation in one word it would be "chaotic."

At a conference in Mountain View, Calif., in January, the director of the US Food and Drug Administration's Office of In Vitro Diagnostics described the regulatory environment for the field as such, but then went on to provide some insights on what FDA's device division is doing to bring more clarity to the molecular diagnostics industry.

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