FDA-Track provides monthly performance data
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
In early April FDA launched a new performance management system that will assess more than 300 activities in its 100-plus offices, dubbed FDA-Track. Managers will report specific actions, which are posted every month for public viewing. For example, in January FDA received 52,101 adverse event reports, approved two REMS and granted approval to two first generics. Activities are tracked and analyzed through FDA-Track dashboards; CDER has dashboards for 10 offices, though data has not yet been compiled for several of those. FDA-Track is part of FDA's transparency initiative, its implementation of the Obama Administration's directive to agencies to be more transparent (1"The Pink Sheet" DAILY, April 7, 2010)