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 in...

I think we all agree that fostering innovation helps American patients and aids in creating American jobs.

Substantial equivalence does not necessarily equate clearance, and your own information that you sent to a company that receives a substanti...

We have heard from many stakeholders that the provisions that were put in place have limited FDA's ability.