Richard Burr said...

I as an applicant should feel good about that. That tells me that there are less people working on application.

More than 278 therapies have been approved under the accelerated approval pathway over the 30 year history, saving and i...

Yes, it will be extended because 60 days from now is past July 15th, right?

Why did FDA agree, and why did the industry agree to longer review times of 128 days on 510(k)'s and provide the agency ...