Thank you, Chairman Pitts.
So it is more a question of the resources than new authority then?
Are there any new authorities that would help the FDA in making sure that companies meet those responsibilities?
I think that it is our responsibility to do something more comprehensive to provide the guidance, Mr. Chairman.
I regret that this committee has not taken a more proactive approach to securing these facilities.
I think the failure of the Department to complete security plan approvals and compliance inspections is a very serious i...
Do you think that the Department must play a role? I mean, do you think that it is absolutely necessary that they play a...
I welcome today's hearing and I am very much looking forward to working together on the critical business of this subcom...
PDUFA has been a remarkable success, giving patients access to safe, effective and breakthrough medical treatments.
I think that our safety and efficacy standards are very important to the success of industry as well as to improving and...
In fact, there is a bill, the Food and Drug Administration Mission Reform Act, that would accomplish this.