About FDA
Manufacturing Supplemental ANADAs and Reactivations
FY 2009 AGDUFA Performance Report Table of Contents
Goal: Review and act on manufacturing supplemental ANADAs and reactivations
The table below summarizes the review time and performance goals for manufacturing supplemental ANADAs and reactivations. Over the 5-year period defined by AGDUFA, the number of review days is incrementally reduced for each type of submission while the goal of reviewing 90 percent of submissions remains constant.
Application Type | Review Time Goal (Days) | Performance | ||||
|---|---|---|---|---|---|---|
FY 2009 | FY 2010 | FY 2011 | FY 2012 | FY 2013 | ||
Manufacturing | 600 | 570 | 420 | 340 | 270 | 90% on time |
Workload
During FY 2009, 102 manufacturing supplemental applications were submitted and 100 were filed (see corresponding graph and table.)
Manufacturing Supplemental ANADAs and Reactivations Filed
Type | FY 09 | FY 10 | FY 11 | FY 12 | FY 13 |
|---|---|---|---|---|---|
Manufacturing Supplemental | 100* | -- | -- | -- | -- |
Total | 100 | -- | -- | -- | -- |
* A total of 102 submissions were received but 1 manufacturing supplemental ANADA received a refuse to accept and 1 submission was withdrawn.
Performance
FY 2009 Submissions
As of September 30, 2009, performance data was available for 6 of 100 manufacturing supplemental ANADAs and reactivations, and FDA met the review time goal for all submissions (see table below). With 94 submissions still pending within goal, FDA has the potential to exceed the performance goal.
Supplemental ANADA and Reactivation Type | Filed | Performance Goal | Performance as of | |||
|---|---|---|---|---|---|---|
Act on | On Time | Overdue | Percent On Time | Pending | ||
Manufacturing | 100 | 600 days | 6 | 0 | 100% | 94 |
Next page: JINAD Submissions
