Barbara Mikulski actually said...

"I am also deeply troubled by the demonization. It has shifted focus away from the regulatory process and the IOM report."

"But this issue of totally replacing the 510(k) gives us pause, and I think one of the reasons it gives us pause is the looming question of who would design the new system?"

"I think that we need to understand that the first obligation you have is for the safety of patients, not whether or not a company gets the approval in a timely manner."

"I want you and the people who work at the FDA... to know how proud we are of the job they do every day."