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U.S. Department of Health and Human Services

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Number of Fast Track designation requests granted

Dictionary: Fast track is an expedited drug development and review program for new drugs or biologics intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical need.

Information is current as of December 31, 2017.

Fiscal Year - 2018

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TimeTargetNumber
Oct 2017N/A20
Nov 2017N/A13
Dec 2017N/A16
Jan 2018N/ATBD
Feb 2018N/ATBD
Mar 2018N/ATBD
Apr 2018N/ATBD
May 2018N/ATBD
Jun 2018N/ATBD
Jul 2018N/ATBD
Aug 2018N/ATBD
Sep 2018N/ATBD

FY 2018 YTD: 49

Number of applications approved under Accelerated Approval

Dictionary: Accelerated Approval is a regulatory pathway that allows for approval of drugs intended to treat serious or life-threatening diseases and that provide meaningful therapeutic benefit to patients over existing therapies, based on the use of surrogate endpoints reasonably likely to predict clinical benefits or a clinical endpoint other than survival or irreversible morbidity. (See also 21 CFR 314 Subpart H and 601 Subpart E)

Fiscal Year - 2018

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TimeTargetNumber
Oct 2017N/A1
Nov 2017N/A0
Dec 2017N/A0
Jan 2018N/ATBD
Feb 2018N/ATBD
Mar 2018N/ATBD
Apr 2018N/ATBD
May 2018N/ATBD
Jun 2018N/ATBD
Jul 2018N/ATBD
Aug 2018N/ATBD
Sep 2018N/ATBD

FY 2018 YTD: 1

Number of First Generics approved

Dictionary: The first time that a particular drug is approved in generic form.

Fiscal Year - 2018

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TimeTargetNumber
Oct 2017N/A7
Nov 2017N/A9
Dec 2017N/A4
Jan 2018N/ATBD
Feb 2018N/ATBD
Mar 2018N/ATBD
Apr 2018N/ATBD
May 2018N/ATBD
Jun 2018N/ATBD
Jul 2018N/ATBD
Aug 2018N/ATBD
Sep 2018N/ATBD

FY 2018 YTD: 20

Number of orphan drugs addressing rare diseases approved

Dictionary: Orphan drugs are products intended for the safe and effective treatment of rare diseases/disorders that affect fewer than 200,000 U.S. patients.

Fiscal Year - 2018

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TimeTargetNumber
Oct 2017N/A2
Nov 2017N/A8
Dec 2017N/A4
Jan 2018N/ATBD
Feb 2018N/ATBD
Mar 2018N/ATBD
Apr 2018N/ATBD
May 2018N/ATBD
Jun 2018N/ATBD
Jul 2018N/ATBD
Aug 2018N/ATBD
Sep 2018N/ATBD

FY 2018 YTD: 14

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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