We face huge risks. We talked earlier about pharmaceuticals that kill people and cause children to be born with flippers.
the House recently passed H.R. 2112, the fiscal year '12 agriculture appropriations bill, which would cut the FDA budget by roughly 11 perce...
will the proposed cut jeopardize the number of review staff that FDA is able to employ at the center? Yes or no.
one of the complaints that my office consistently receives is that medical device approval process has a certain inconsistency from reviewer...
Now, there are some areas of improvement in the current medical device approval process but I would ask my colleagues here, does anybody rem...
So is there anybody around here that wants to return to what President Ford called the horse and buggy days of device regulation?
As you know, class III devices are devices by their nature that should require a stricter review by FDA.
will the proposed cut have a detrimental impact on any efforts to improve reviewer training at the center?
Do you believe that the clinical trial standards laid out by FDA in the premarket approval process are rigorous enough to prove safety and e...
Do you believe that the current postmarket surveillance requirements are adequate?
Do you believe that the device manufacturers have met their responsibility to conduct rigorous postmarket surveillance to ensure the safety ...