06/02/2011
https://congress.gov...
"The drug and device user fee programs ensure that FDA gets critical dollars to allow the agency to complete its premarket review in a timely manner."
"We must reauthorize and establish these essential programs in a timely way so that FDA can do its job protecting the health and safety of American patients."
"Well, we all want these drugs on the market as fast as possible but I would be concerned about any proposal to remove FDA's ability to require clinical data when FDA thinks it is essential to assure t..."
"I agree, it is critical to retain that sunset provision so we have an opportunity to evaluate these questions, both the balance and the research questions as well."