So, why are medical devices different than drugs?
More than 30 years ago, Senator Kennedy championed the Medical Device Amendments, a bill that gave the Food and Drug Adm...
It was inevitable that something like this would happen.
The Committee on Health, Education, Labor, and Pensions will come to order for this hearing on protecting patients from ...
They could penalize the company. They could seize the offending illegal products.
Senator Kennedy, as he did 30 years ago, is fighting to ensure that consumers are safe.
This bill is really about real people who have been let down--let down, sometimes catastrophically.
If a device manufacturer commits fraud on the FDA, puts a device out there, and injures people--but, they cannot sue and...
I must also say, regardless of the difference between drugs and devices, we're getting new drugs on the market all the t...
I happen to be for innovation, I happen to be for new devices, I happen to think that these are good things, but I also ...
But, under Riegel, if there is--if they can say, 'My gosh, we'll never have to give those documents up.'
I don't care how small they are, they'd better meet the most stringent standards of safety and efficacy.
We should give them the resources. We've asked them to do a myriad of things, and yet we don't give them the resources t...
Well, the ultimate goal is to get the very best devices we can to really help people like Mr. Mulvihill, like Mr. Roman,...
I think sometimes they do good things, other times they don't do what they should be doing.
So, it doesn't go right back and go through the whole process again.
I was just reminded by my staff that we change drugs all the time for kids--change them all the time--for dosages and re...
Manufacturers who commit fraud on the FDA are not immune from lawsuits.
