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Susan Bro
decision examining next ruling steps
We are examining the ruling and have not made a decision yet as to what are next steps will be.
best carried cooperate devices including oversight prudent requires safe safety timely undergoing
The safe use of these important devices requires the involvement of many, including the companies. Safety oversight is something that is always undergoing important improvements and is best carried out when all cooperate in a timely and prudent manner.
company continuing draw final identified issues premature process step work
We are continuing to work with the company to see that all of the issues that have been previously identified are being addressed. It's premature to draw any conclusions from this step in the process. The re-inspection process is still under way and final conclusions have not been determined.
congress including position response
In response to inquiries, including from Congress, we are clarifying our position on the science.
abroad additional both determine fda guidance liver medicine problems somewhat warning whether
Because these liver problems are significant and somewhat idiosyncratic or unpredictable, the FDA is evaluating the use of this medicine in both the U.S. and abroad where it is used and marketed to determine whether additional warning guidance is merited.