PMA Decision Times Edged Upward, Likely Due To More Advisory Panels
This article was originally published in The Gray Sheet
Executive Summary
The total time to decision seems to have increased for original PMAs submitted in FY 2013 based on interim data. The upward trend may be due to an unusually high proportion of advisory panels scheduled for that cohort of applications, which FDA believes is settling back to normal for FY 2014 applications.