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Percentage of Biologics License Application (BLA) manufacturing supplements with action due dates occurring during the month that were reviewed and acted upon within 4 months of receipt (1)
Dictionary: Licensed manufacturers must submit a prior approval supplement to FDA for any change to a product that has a substantial impact to have an adverse effect on the identity, strength, quality, purity or potency of the product as they may relate to the safety or effectiveness of the product. Examples of such changes include production process, quality controls, equipment, facilities, or responsible personnel. FDA approval must be obtained prior to distribution of the product made with the change. This measure will allow OVRR to monitor its performance in issuing decisions for manufacturing supplements requiring prior approval within established timeframes.
Information is current as of September 30, 2012
Fiscal Year - 2010
| Time | Target | Percent |
|---|---|---|
| Apr 2010 | 90 | 100 |
| May 2010 | 90 | 100 |
| Jun 2010 | 90 | 100 |
| Jul 2010 | 90 | 100 |
| Aug 2010 | 90 | 100 |
| Sep 2010 | 90 | 100 |
FY 2010 6-month Overall: 100%
Footnotes
- (1) OVRR revised this measure from standard efficacy supplements to BLA manufacturing supplements based on revised FDA-TRACK program guidance. Tracking against this measure did not begin until April 2010.
Number of BLA manufacturing supplements with action-due dates occurring during the month that were reviewed and acted upon within 4 months of receipt
Fiscal Year - 2010
| Time | Target | Number |
|---|---|---|
| Apr 2010 | N/A | 10 |
| May 2010 | N/A | 7 |
| Jun 2010 | N/A | 9 |
| Jul 2010 | N/A | 7 |
| Aug 2010 | N/A | 2 |
| Sep 2010 | N/A | 5 |
FY 2010 6-month Total: 40
Number of BLA manufacturing supplements with action-due dates occurring during the month
Fiscal Year - 2010
| Time | Target | Number |
|---|---|---|
| Apr 2010 | N/A | 10 |
| May 2010 | N/A | 7 |
| Jun 2010 | N/A | 9 |
| Jul 2010 | N/A | 7 |
| Aug 2010 | N/A | 2 |
| Sep 2010 | N/A | 5 |
FY 2010 6-month Total: 40
Glossary
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.
