Those decisions that so swayed the FDA to avoid asserting its authority and jurisdiction were also unclear, limited, and contested.
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...
I'm suggesting to you that the jurisdiction ought to be asserted as widely and effectively as possible and that there be...
I would suggest to you that the jurisdictional question ought to be resolved very simply and starkly. If a company manuf...
The Congress really should be meeting its obligation to provide those resources that are necessary for the tasks that we...
Shouldn't you know?
Your job--and it is uniquely and always the job of the Federal Government to establish standards that protect the public...
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.
So if I can sort of distill your answer into one sentence, the answer to the question depends on the plan document curre...