05/24/2011
https://congress.gov...
"Are today's GMPs sufficient to ensure manufacturing quality, yes or no?"
"Is that sufficient or not?"
"I commend you for the hearing today with regard to the FDA amendments that we are discussing with regard to PDUFA."
"These are authorities that would be given FDA under H.R. 1483, the drug safety bill I introduced with my colleagues Mr. Waxman, Mr. Pallone and Mrs. DeGette."