06/02/2015
https://www.congress.gov...
"Can you report anything about the status of those negotiations, or is that beyond your----"
"I hope our focus in this hearing will continue to be how do we make certain that FDA is doing its job well."
"Is there a timeframe in which you would expect that consequences to Congress to occur?"
"You indicated in your testimony and in part in response to my questions that often substance within the application process, substance within that application is insufficient for an approval."