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Number of Biologics License Application (BLA) manufacturing supplements received in the quarter
Dictionary: These measures show marketing applications received during the quarter as well as various actions taken during the quarter. BLA manufacturing supplements are submissions that propose changes to a licensed products’ approved manufacturing process.
Information is current as of September 30, 2021
Fiscal Year - 2021
| Time | Target | Number |
|---|---|---|
| Oct - Dec 2020 | N/A | 280 |
| Jan - Mar 2021 | N/A | 266 |
| Apr - Jun 2021 | N/A | 261 |
| Jul - Sept 2021 | N/A | 247 |
FY 2021 Total: 1054
Number of overdue BLA manufacturing supplements at the end of the quarter
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
Number of actions taken on BLA manufacturing supplements in the quarter that were within goal dates
Fiscal Year - 2021
| Time | Target | Number |
|---|---|---|
| Oct - Dec 2020 | N/A | 263 |
| Jan - Mar 2021 | N/A | 249 |
| Apr - Jun 2021 | N/A | 280 |
| Jul - Sept 2021 | N/A | 303 |
FY 2021 Total: 1095
Number of actions taken on BLA manufacturing supplements in the quarter that were past goal dates
Fiscal Year - 2021
| Time | Target | Number |
|---|---|---|
| Oct - Dec 2020 | N/A | 1 |
| Jan - Mar 2021 | N/A | 4 |
| Apr - Jun 2021 | N/A | 5 |
| Jul - Sept 2021 | N/A | 6 |
FY 2021 Total: 16
Number of actions taken on Biologics License Application (BLA) manufacturing supplements in the quarter
Dictionary: These measures show marketing applications received during the quarter as well as various actions taken during the quarter. BLA manufacturing supplements are submissions that propose changes to a licensed products’ approved manufacturing process.
Fiscal Year - 2021
| Time | Target | Number |
|---|---|---|
| Oct - Dec 2020 | N/A | 264 |
| Jan - Mar 2021 | N/A | 253 |
| Apr - Jun 2021 | N/A | 285 |
| Jul - Sept 2021 | N/A | 309 |
FY 2021 Total: 1111
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.
