About FDA
Number of Fast track designations granted in the quarter
Dictionary: These processes are reserved for submissions that are intended to treat serious or life-threatening conditions, and to facilitate the development and expedite the review of biologics that demonstrate the potential to address unmet medical needs. Fast track designation is intended to facilitate the development, and expedite the review of a product to treat serious or life-threatening conditions, and nonclinical or clinical data demonstrate the potential to address an unmet medical need.
Information is current as of September 30, 2021
Fiscal Year - All
| Time | Target | Number |
|---|---|---|
| October – December 2012 | N/A | 5 |
| January – March 2013 | N/A | 3 |
| April – June 2013 | N/A | 6 |
| July – September 2013 | N/A | 3 |
| October – December 2013 | N/A | 1 |
| January – March 2014 | N/A | 3 |
| April – June 2014 | N/A | 4 |
| July – September 2014 | N/A | 3 |
| October – December 2014 | N/A | 7 |
| January – March 2015 | N/A | 4 |
| April – June 2015 | N/A | 5 |
| July – September 2015 | N/A | 9 |
| October – December 2015 | N/A | 4 |
| January – March 2016 | N/A | 1 |
| April – June 2016 | N/A | 8 |
| July – September 2016 | N/A | 6 |
| October – December 2016 | N/A | 6 |
| January – March 2017 | N/A | 10 |
| April – June 2017 | N/A | 11 |
| July – September 2017 | N/A | 7 |
| October – December 2017 | N/A | 7 |
| January – March 2018 | N/A | 4 |
| April – June 2018 | N/A | 10 |
| July – September 2018 | N/A | 6 |
| October – December 2018 | N/A | 13 |
| January – March 2019 | N/A | 8 |
| April – June 2019 | N/A | 9 |
| July – September 2019 | N/A | 2 |
| Oct - Dec 2019 | N/A | 1 |
| Jan - Mar 2020 | N/A | 11 |
| Apr - Jun 2020 | N/A | 8 |
| Jul - Sept 2020 | N/A | 16 |
| Oct - Dec 2020 | N/A | 15 |
| Jan - Mar 2021 | N/A | 15 |
| Apr - Jun 2021 | N/A | 2 |
| Jul - Sept 2021 | N/A | 13 |
Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.
