07/16/2014
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..."
"the academy also wishes to acknowledge and thank Representatives Mike Rogers and Ed Markey, who together authored the Pediatric Medical Device Safety and Improvement Act of 2007."
"So if you would be willing to work with us, we are willing to work with you and with Mr. Pallone and others to see if we can do something legislatively in this area."