Frank Pallone actually said...

MDUFA has been a success in addressing these issues, reducing the average total time to a decision on a pre-market approval in 2015 by 35 pe...

I am committed to working with my colleagues across the aisle and across the Capitol to ensure that we meet this deadline.

if we do not reauthorize MDUFA by September 30th, CDRH would lose about one-third of its personnel.

the statute outlines a detailed process for reauthorization that requires FDA to not only negotiate with industry to develop recommendations...