Senator Elizabeth Warren at a rally in Cambridge, Massachusetts, in September. Photo by Scott Eisen, Getty Images
October 10, 2018
The FDA’s Pre-Cert program has fallen under new scrutiny as the agency received an open letter today from three senators: Elizabeth Warren (D-Mass.), Patty Murray (D-Wash.), and Tina Smith (D-Minn.).
The 12-page letter contains no less than 50 questions for the agency about the program, ranging from how it will derive its statutory authority to how it will pay for the program absent traditional...