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U.S. Department of Health and Human Services

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Total number of orphan drug designation decisions that resulted in orphan designation in the month

Dictionary: OOPD will track the monthly number of orphan drug designation requests (original or amended) that resulted in an orphan drug designation because the sponsor’s request met the regulatory criteria for an orphan designation, allowing sponsors to take advantage of special incentives provided in the Orphan Drug Act.

Information is current as of September 30, 2020.

Fiscal Year - All

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TimeTargetNumber
Oct 2010N/A13
Nov 2010N/A22
Dec 2010N/A23
Jan 2011N/A15
Feb 2011N/A22
Mar 2011N/A16
Apr 2011N/A26
May 2011N/A9
Jun 2011N/A24
Jul 2011N/A13
Aug 2011N/A11
Sep 2011N/A20
Oct 2011N/A14
Nov 2011N/A8
Dec 2011N/A17
Jan 2012N/A8
Feb 2012N/A17
Mar 2012N/A22
Apr 2012N/A11
May 2012N/A8
Jun 2012N/A14
Jul 2012N/A31
Aug 2012N/A9
Sep 2012N/A25
Oct 2012N/A13
Nov 2012N/A14
Dec 2012N/A22
Jan 2013N/A23
Feb 2013N/A6
Mar 2013N/A22
Apr 2013N/A19
May 2013N/A23
Jun 2013N/A15
Jul 2013N/A12
Aug 2013N/A22
Sep 2013N/A43
Oct 2013N/A28
Nov 2013N/A23
Dec 2013N/A21
Jan 2014N/A18
Feb 2014N/A21
Mar 2014N/A12
Apr 2014N/A28
May 2014N/A30
Jun 2014N/A27
Jul 2014N/A21
Aug 2014N/A24
Sep 2014N/A26
Oct 2014N/A31
Nov 2014N/A26
Dec 2014N/A26
Jan 2015N/A37
Feb 2015N/A35
Mar 2015N/A42
Apr 2015N/A30
May 2015N/A30
Jun 2015N/A29
Jul 2015N/A26
Aug 2015N/A13
Sep 2015N/A29
Oct 2015N/A24
Nov 2015N/A24
Dec 2015N/A32
Jan 2016N/A18
Feb 2016N/A41
Mar 2016N/A20
Apr 2016N/A27
May 2016N/A36
Jun 2016N/A30
Jul 2016N/A24
Aug 2016N/A32
Sep 2016N/A33
Oct 2016N/A20
Nov 2016N/A33
Dec 2016N/A19
Jan 2017N/A50
Feb 2017N/A31
Mar 2017N/A25
Apr 2017N/A22
May 2017N/A21
Jun 2017N/A87
Jul 2017N/A48
Aug 2017N/A52
Sep 2017N/A44
Oct 2017N/A33
Nov 2017N/A35
Dec 2017N/A29
Jan 2018N/A29
Feb 2018N/A30
Mar 2018N/A40
Apr 2018N/A29
May 2018N/A29
Jun 2018N/A23
Jul 2018N/A19
Aug 2018N/A22
Sep 2018N/A21
Oct 2018N/A43
Nov 2018N/A23
Dec 2018N/A27
Jan 2019N/A19
Feb 2019N/A49
Mar 2019N/A20
Apr 2019N/A19
May 2019N/A23
Jun 2019N/A32
Jul 2019N/A30
Aug 2019N/A39
Sep 2019N/A24
Oct 2019N/A30
Nov 2019N/A26
Dec 2019N/A28
Jan 2020N/A31
Feb 2020N/A22
Mar 2020N/A44
Apr 2020N/A44
May 2020N/A31
Jun 2020N/A39
Jul 2020N/A41
Aug 2020N/A43
Sep 2020N/A58

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.

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