Do you believe that a single study is sufficient to approve a class III device?
Thalidomide.
Do you believe that the clinical trial standards laid out by FDA in the premarket approval process are rigorous enough t...
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 t...
Way back, we had a nasty experience in this country. It related to a substance which caused problems with regard to babi...
if the proposed cuts to the FDA budget included in H.R. 2112 are enacted, will FDA have to lay off employees? Yes or no.
We face huge risks. We talked earlier about pharmaceuticals that kill people and cause children to be born with flippers...
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 inconsi...
Now, there are some areas of improvement in the current medical device approval process but I would ask my colleagues he...
So is there anybody around here that wants to return to what President Ford called the horse and buggy days of device re...
Absent compelling national security related concern, have you heard of a Federal agency not answering a congressional re...
I am going to try and see that they are pounded about the head and shoulders until they come forward with these answers.
Should it?
Mr. Chairman, you are most courteous; and I thank you.
I am concerned this may preclude the Secretary from considering other information...
Starting with you, Mr. Black, yes or no, is this something the industry is doing already?
