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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 September 30, 2021
Fiscal Year - 2021
| Time | Target | Number |
|---|---|---|
| Oct - Dec 2020 | N/A | 208 |
| Jan - Mar 2021 | N/A | 182 |
| Apr - Jun 2021 | N/A | 197 |
| Jul - Sept 2021 | N/A | 190 |
FY 2021 Total: 777
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 - 2021
| Time | Target | Number |
|---|---|---|
| Oct - Dec 2020 | N/A | 3 |
| Jan - Mar 2021 | N/A | 7 |
| Apr - Jun 2021 | N/A | 9 |
| Jul - Sept 2021 | N/A | 5 |
FY 2021 Total: 24
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 - 2021
| Time | Target | Number |
|---|---|---|
| Oct - Dec 2020 | N/A | 544 |
| Jan - Mar 2021 | N/A | 325 |
| Apr - Jun 2021 | N/A | 378 |
| Jul - Sept 2021 | N/A | 312 |
FY 2021 Total: 1559
Number of actions taken on Original INDs and IDEs in the quarter that were past goal dates
Fiscal Year - 2021
| Time | Target | Number |
|---|---|---|
| Oct - Dec 2020 | N/A | 0 |
| Jan - Mar 2021 | N/A | 0 |
| Apr - Jun 2021 | N/A | 0 |
| Jul - Sept 2021 | N/A | 0 |
FY 2021 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.
