Drugmakers Waiting for Closeouts After Resolving Warning Letters

Although FDA Commissioner Margaret Hamburg predicted last year that regulated companies that get warning letters would really want a closeout letter, the problem is most of them aren’t getting them. As of Nov. 5, only 4 percent of drugmakers and 7 percent of devicemakers that had received a warning letter since Hamburg’s new enforcement policy went into effect Sept. 1, 2009, have received a closeout letter, according to the FDA’s warning letter database.
Washington Drug Letter