06/20/2012
https://www.congress.gov...
"I've had extensive experience with the FDA, and they don't miss much."
"A supplemental PMA, which is required for any change of any kind, is required to be approved by FDA, using the same standards of safety and effectiveness as the original PMA."
"I am very proud of you for accepting this position."
"I know that Senator Leahy and I and others on this Committee work very strongly together to try and help bring about the effective changes."