09/24/2019
https://congress.gov...
"FDA's guidance is very measured and risk-based."
"I have no doubt that the sponsors of the bill had no intention of exempting such apps from oversight."
"I have several concerns about this bill starting with the timing."
"These provisions were based on the ideas and proposals contained in the Drug Safety Enhancement Act, which I introduced with Mr. Dingell, Mr. Waxman, and Ms. DeGette."