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U.S. Department of Health and Human Services

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Number of Original Investigational New Drug (IND) applications received in the quarter

Dictionary: This measure shows the total number of commercial, research, and emergency INDs received in the month in addition to total actions taken on these submissions. An IND or an Investigational Device Exemption (IDE) application is submitted to the FDA to request permission to conduct U.S. clinical trials using investigational products. Commercial INDs and IDEs reflect new products under development that are eventually intended to support a marketing application. Any non-commercial INDs and IDEs are considered Research INDs and IDEs

Information is current as of June 30, 2019

Fiscal Year - 2018

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TimeTargetNumber
October – December 2017N/A141
January – March 2018N/A194
April – June 2018N/A162
July – September 2018N/A178

FY 2018 Total: 675

Number of Original Investigational Device Exemptions (IDEs) received in the quarter

Dictionary: This measure shows the total number of commercial, research, and emergency INDs / IDEs received in the month in addition to total actions taken on these submissions. An IND or an IDE application is submitted to the FDA to request permission to conduct U.S. clinical trials using investigational products. Commercial INDs and IDEs reflect new products under development that are eventually intended to support a marketing application. Any non-commercial INDs and IDEs are considered Research INDs and IDEs

Fiscal Year - 2018

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TimeTargetNumber
October – December 2017N/A2
January – March 2018N/A6
April – June 2018N/A3
July – September 2018N/A2

FY 2018 Total: 13

Number of actions taken on Original Investigational New Drug (IND) applications and Investigational Device Exemptions (IDEs) in the quarter

Dictionary: These measures show the total number of commercial, research, and emergency INDs / IDEs received in the month in addition to total actions taken on these submissions. An IND or an IDE application is submitted to the FDA to request permission to conduct U.S. clinical trials using investigational products. Commercial INDs and IDEs reflect new products under development that are eventually intended to support a marketing application. Any non-commercial INDs and IDEs are considered Research INDs and IDEs

Fiscal Year - 2018

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TimeTargetNumber
October – December 2017N/A267
January – March 2018N/A275
April – June 2018N/A288
July – September 2018N/A394

FY 2018 Total: 1,224

Number of actions taken on Original INDs and IDEs in the quarter that were past goal dates

Fiscal Year - 2018

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TimeTargetNumber
October – December 2017N/A0
January – March 2018N/A0
April – June 2018N/A0
July – September 2018N/A0

FY 2018 Total: 0

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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