12/01/1997
https://www.congress.gov...
I went through a litany in my opening statements of the deficiencies in what FDA committed to and what they missed.
More than 278 therapies have been approved under the accelerated approval pathway over the 30 year history, saving and i...
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 ...
Without Orrin, we wouldn't have a generic drug industry.