01/27/2009
https://www.congress.gov...
"I consider the FDA to be the gold standard globally in approving drugs and I find this court ruling to be more reflective of the judge's personal views rather than a fair and impartial analysis of the..."
"I am concerned that the lack of face-to-face meetings may be negatively affecting the FDA's ability to keep pace and retain its scientific and regulatory stature as the gold standard."
"We are going to be, shortly, reintroducing that bipartisan bill. It proposes critical reforms to increase the effectiveness and impact of USAID's maternal and child survival programs."
"Clinical holds can be an important and appropriate tool for the Agency to utilize when a potential concern with an application has surfaced, but they are not a substitute for timely, constructive, and..."