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?
If you're going to criticize FDA for approval, criticize us for bill approval.
I think that we need to understand that the first obligation you have is for the safety of patients, not whether or not ...
I am also deeply troubled by the demonization. It has shifted focus away from the regulatory process and the IOM report.
I want you and the people who work at the FDA... to know how proud we are of the job they do every day.
We're facing a joint committee report. If the joint committee fails to act, or we fail to adopt the joint committee reco...
I think what we need is to value our civil servants, and let them know they can count on us.
dump it and deal with it.
the letter cosponsored by Senators Mikulski and Hutchison, co-signed by all the women senators and others, to the Suprem...
President Obama issued an Executive order on October 31 to immediately take action to reduce shortages; but we can and m...
Senator Mikulski was talking about the changing labor force and how policy is still reacting to a previous design of lab...