06/18/2012
https://www.congress.gov...
"I want to thank Senator Harkin for chairing this hearing in the absence of our esteemed chairman of the committee."
"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."