As we talked about, as part of our inspection program, we go into different companies and verify that they have a system in place to do the adverse reaction reporting that's required. We also work with Chris's group. Remember we talked about signals? If a signal comes in and requires an investigation or an inspection, it moves to this side of the house, and then we come in, and we'll investigate or inspect the information and then decide if there's any compliance and enforcement action required as a result of that information.
On January 31st, 2008. See this statement in context.