CBER 510(k) Increase In FY 1999 Likely; Review Times Parallel FY 1998
This article was originally published in The Gray Sheet
Executive Summary
FDA's Center for Biologics Evaluation and Research has taken first action within 90 days of receipt on only nine of 25 traditional and abbreviated 510(k)s received so far during fiscal year 1999, according to a June 1 report developed by the center's Office of Blood Research and Review.