FDA Advisory Panel Finds Hologic

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