About FDA
ANADAs and Reactivations
FY 2009 AGDUFA Performance Report Table of Contents
Goal: Review and act on original ANADAs and reactivations and administrative ANADAs
The table below summarizes the review time and performance goals for original ANADAs and reactivations, and administrative ANADAs. 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 Goal | ||||
|---|---|---|---|---|---|---|
FY 2009 | FY 2010 | FY 2011 | FY 2012 | FY 2013 | ||
Original ANADAs and Reactivations | 700 | 680 | 500 | 380 | 270 | 90% on time |
Administrative | 120 | 115 | 110 | 105 | 100 | |
Workload
During FY 2009, 16 original applications were received and 13 were filed. No administrative ANADAs were filed in FY 2009 (see corresponding graph and table).
ANADAs and Reactivations Filed
Type | FY 09 | FY 10 | FY 11 | FY 12 | FY 13 |
|---|---|---|---|---|---|
Original ANADAs and Reactivations | 13* | -- | -- | -- | -- |
Administrative ANADAs | 0 | -- | -- | -- | -- |
Total | 13 | -- | -- | -- | -- |
* A total of 16 submissions were submitted but 1 received a refuse to accept notification and 2 received a refuse to file.
Performance
FY 2009 Submissions
As of September 30, 2009, performance data was available for one of 13 original ANADAs and reactivations, and FDA met the review time goal for the submission (see table below). With 12 submissions still pending within goal, FDA has the potential to exceed the performance goal.
| ANADA and Reactivation Type | Filed | Performance Goal | Performance as of September 30, 2009 | |||
|---|---|---|---|---|---|---|
| Act on 90 Percent Within | On Time | Overdue | Percent On Time | Pending Within Goal | ||
| Original | 13 | 700 days | 1 | 0 | 100% | 12 |
| Administrative | 0 | 120 days | 0 | 0 | -- | 0 |
Next page: Manufacturing Supplemental ANADAs and Reactivations
