"We have had some problems with the Gateway," Roger Goetsch, FDA director of regulatory affairs, said at the DIA meeting.
"We're still dealing with paper.
Our regulation says: paper."
also declined to explain the pace of modernization of its safety systems, or its plans to encourage the industry to supply more reports electronically.
At DIA, however, Goetsch
said, "We know [the amount of reports] is going to go up 10 to 15 percent a year.
We can't hand-type these in.