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FDAAA and labeling

Executive Summary

Former FDAer Greg Burkhart, Burkhart & Freiman, proposes that one aspect of newfound authority that FDA will embrace is the ability to mandate product labeling changes. "You're going to see something a little bit different regarding how safety information may get into the label. There is going to a much bigger push I think coming from certain parts of the agency. It's going to be very difficult for the divisions ... to resist such changes," he said at the DIA session. Disagreements within FDA over the appropriate treatment of safety information have recently been exposed to the public (1"The Pink Sheet" Aug. 6, 2007, p. 6). "It will change the way that the sponsors are notified when FDA thinks something is going on. Before it had to have a high threshold before FDA would even bother because a lot of times there would be a fight. I don't think that is going to be the case anymore. I think things are going to get into the label now from the FDA viewpoint that may have a lower threshold"...

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