Well, of course all that could be limited under rules that could be established by the courts for defining what amount of discovery and putting very narrow deadlines on that.
Over use of antipsychotics, as I don't need to tell the two witnesses and probably most of the people who are attending today, is a form of ...
I noticed that at least two of the witnesses wanted to respond to your point.
Isn't there the very real danger... that the exception of the waiver would swallow the rule?
There's been discussion here about a debate with the American people. If we're going to have a debate, item one on the debate should be, are...
If a Congress then turned around and started violating the express wishes of the American public with great frequency, I can't believe that ...
But the major obstacle that you have identified, and I think very plausibly and correctly, is the time line and the amount of work and time ...
I am going to adjourn this hearing and leave the record open for 1 week in case there are additional questions from any of the Senators.
postmarket is really no substitute for fundamental reform of the entire 510(k) system.
the present system simply isn't working, that it's broken, and, in fact, fatally defective.
even under existing authority, the FDA has the power to be more vigilant and vigorous in protecting the public.