Foreign drug manufacturers are having a time of it these days. On top of the confusion and controversy caused by tariffs, layer FDA’s increasingly aggressive and renewed promises to dramatically expand its foreign drug inspection program. These moves are potentially a potent one-two punch of compliance headaches that could reshape the international drug manufacturing landscape. A coming court ruling on tariffs will be public, but the results of any promised foreign inspection buildup may take years to compile and fully understand. That isn’t stopping Commissioner Marty Makary from talking tough about changes he wants to see happen in this space...[FDABlog]
