Michael Burgess actually said...

"We need to reauthorize the user fees by the end of June to assure continuity at the FDA and increase predictability for America's medical innovators and job creators."

"Yes, but this is something that people just frankly do not understand why one federal agency and another federal agency cannot come together on a reasonable solution."

"Substantial equivalence does not necessarily equate clearance, and your own information that you sent to a company that receives a substantial equivalence determination, 'Please be advised the FDA's i..."

"I appreciate the fact that you are working through this problem with getting a new over-the-counter preparation available, but as you pointed out, you have difficulty with bioequivalency."