In 24 years, I have done a lot of hearings. I found it almost impossible to have an agency witness at the table who testified and the private panel comes up second, and get an agency person to stay in the room to listen to the private sector.
Burr reflects on the rarity of agency witnesses attending hearings.
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He was also the author of the Americans With Disabilities Act, helping improve the lives of millions of Americans with disabilities.
I question whether the agreements both passed and proposed reflect a good deal for patients they are designed to serve.
I always like to bring things back to the present because I have a tremendous amount of respect for all four of you.
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 with so much more money?
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