September 12, 2017 | Three months ago, the FDA committed to fully eliminate a backlog of about 200 orphan drug designation requests that were pending review with FDA, and to implement policies that would require FDA to respond to all new designation requests within 90 days of receiving them. Moreover, the agency pledged to never allow a backlog of these designations to accumulate again. Here is their progress in meeting each of these objectives. They also said that they may pursue other policies that they believe would enable them to better advance the goals of the Orphan Drug Act (ODA). Here is an update on their progress in meeting each of these objectives. FDA Voice