01/15/2014
https://www.congress.gov...
"So if another researcher decided to pursue clinical trials of this same drug, they would have no idea about the dangers identified from the previous trial and would put more people at risk of the same..."
"So this is something that Ms. Eshoo and I are working on, this next subject, which is that the FDA data shows that since 2007, 78 percent of PREA's pediatric study requirements were not completed by t..."
"I see no reason, Ms. Eshoo and I agree on this, that companies failing to meet their obligations to children should enjoy those special protections."
"Do you agree that any clinical trial regardless of where it takes place should be subject to the same transparency requirements if the trial is used as part of the company's approval application to th..."