FDA Advisory Panel Finds Hologic

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The FDA is not required to accept, but traditionally follows the recommendations of its advisory panels. The panel recommended approval of the device contingent upon several conditions, including long-term follow up of current pivotal trial patients, a new post approval study of new patients and physicians, and more specific labeling recommendations.

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Published on : Fri, 14 Dec 2007


The FDA is not required to accept, but traditionally follows the recommendations of its advisory panels. The panel recommended approval of the device co

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