I would suggest to you that the jurisdictional question ought to be resolved very simply and starkly. If a company manufactures drugs, you regulate them now, do you not?
The Congress really should be meeting its obligation to provide those resources that are necessary for the tasks that we...
Thank you, Mr. Chairman. I'd like to pursue, Mr. Chairman, your questions at the very outset here about the Ameridose ma...
I would just suggest that you be preventive with a capital P, and that you regard these renegade, outlier drug manufactu...
There was no warning letter ever sent.
Those decisions that so swayed the FDA to avoid asserting its authority and jurisdiction were also unclear, limited, and...
Unfortunately, having reviewed many of these documents, having spoken to experts in the field, having reviewed the histo...
I do think that we should know, and I would like to see that as part of new legislation if we would do it.
Clearly, serious, egregious violations of basic standards were found by your inspectors in 2008 and then again in 2010.
I think that a lot of the questioning that you're seeing here reflects a skepticism on the part of Congress and the publ...
So if I can sort of distill your answer into one sentence, the answer to the question depends on the plan document curre...