CDRH sets new product review goals
This article was originally published in Clinica
Executive Summary
The FDA's product reviewers within the device centre (CDRH) are being asked to abide by yet another goal in order to reduce review times. For both expedited and traditional premarket approval applications, the FDA has committed to reduce review times by 30 days for the fastest 50% of those applications approved for fiscal years 2005 through 2007.