I have been interested in how to fix it for a long time. In fact, when I was the chairman of the subcommittee, we held a hearing in 2009. Quite frankly, both before and after that ...
I think it is unfortunate that after 5 years, I think we should be closer on implementation on what I consider a very cr...
the imbalance of inspection requirements between U.S. and foreign manufacturing facilities creates an uneven playing fie...
Thank you. Now, would it be helpful to have additional resources to conduct more foreign inspections of brand facilities...
As you know, Mr. Dingell, Ms. DeGette, myself, and Mr. Waxman have introduced the Drug Safety Enhancement Act that gives...
We are going to move forward with them.
I am encouraged by the bipartisan nature of these efforts, and I look forward to working with my colleagues.
Clearly, bringing generic drugs to market faster should be a priority.
I am supportive of its passage.
I appreciate the industry's ability to work with the FDA and move forward on a strong agreement.
Both you and the FDA Commissioner Hamburg gave assurances to the generic industry that the Biosimilar User Fee Program w...