Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Early communication pilot program: FDA is conducting a pilot program to evaluate the effectiveness of early communication with manufacturers, Commissioner-designee Lester Crawford reported April 7 at the FDLI annual conference in Washington, D.C. The agency has increased the number of meetings it has with manufacturers, the acting head observed. "It is now time to evaluate just how much good that's doing the company and how much good that's doing FDA," Crawford said. He noted that although the agency believes there may be a need to expand the program in the future, its effectiveness must first be evaluated...