04/23/2013
https://www.congress.gov...
"Is there a timeframe in which you would expect that consequences to Congress to occur?"
"Is there a common denominator for drug companies who are required to submit additional information during the approval process?"
"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."
"I think we are about to wrap up our hearing, assuming I do not talk so long that other members and other Senators arrive."