02/07/2024
https://www.congress.gov...
"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 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..."
"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..."
"The Web site clinicaltrials.gov was transformed into a mandatory registry that I created along with Representative Waxman in the 2007 FDA amendments."