• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

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

Skip graphic and jump to text data

October – December 2012N/A5
January – March 2013N/A3
April – June 2013N/A6
July – September 2013N/A3
October – December 2013N/A1
January – March 2014N/A3
April – June 2014N/A4
July – September 2014N/A3
October – December 2014N/A7
January – March 2015N/A4
April – June 2015N/A5
July – September 2015N/A9
October – December 2015N/A4
January – March 2016N/A1
April – June 2016N/A8
July – September 2016N/A6
October – December 2016N/A6
January – March 2017N/A10
April – June 2017N/A11
July – September 2017N/A7
October – December 2017N/A7
January – March 2018N/A4
April – June 2018N/A10
July – September 2018N/A6
October – December 2018N/A13
January – March 2019N/A8
April – June 2019N/A9
July – September 2019N/A2
Oct - Dec 2019N/A1
Jan - Mar 2020N/A11
Apr - Jun 2020N/A8
Jul - Sept 2020N/A16
Oct - Dec 2020N/A15
Jan - Mar 2021N/A15
Apr - Jun 2021N/A2
Jul - Sept 2021N/A13

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.