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Percentage of times that meeting minutes are sent within 30 days of the meeting date (Prescription Drug User Fee Act [PDUFA]) (1)
Dictionary: OCTGT will prepare minutes which will be available to the sponsor 30 calendar days after the meeting. The minutes will clearly outline, in bulleted form, important agreements, disagreements, issues for further discussion, and action items from the meeting. This measure focuses on the percentage of completed meeting minutes provided to sponsors within established timeframes.
Information is current as of September 30, 2012
Fiscal Year - 2012
| Time | Target | Percent |
|---|---|---|
| Oct 2011 | 90 | 100 |
| Nov 2011 | 90 | 100 |
| Dec 2011 | 90 | 100 |
| Jan 2012 | 90 | N/A |
| Feb 2012 | 90 | 100 |
| Mar 2012 | 90 | 50 |
| Apr 2012 | 90 | 100 |
| May 2012 | 90 | 100 |
| Jun 2012 | 90 | 100 |
| Jul 2012 | 90 | 100 |
| Aug 2012 | 90 | 100 |
| Sep 2012 | 90 | 100 |
FY 2012 Overall: 97%
Footnotes
- (1) Industry Meeting Response Measures only include commercial and non-commercial PDUFA products. Medical Device User Fee Amendment (MDUFA) products are not included.
Number of meeting minutes due during the month that were sent to sponsors within the specified PDUFA timeframes
Fiscal Year - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 1 |
| Nov 2011 | N/A | 4 |
| Dec 2011 | N/A | 2 |
| Jan 2012 | N/A | 0 |
| Feb 2012 | N/A | 2 |
| Mar 2012 | N/A | 1 |
| Apr 2012 | N/A | 5 |
| May 2012 | N/A | 5 |
| Jun 2012 | N/A | 3 |
| Jul 2012 | N/A | 2 |
| Aug 2012 | N/A | 2 |
| Sep 2012 | N/A | 5 |
FY 2012 Total: 32
Number of meeting minutes due during the month
Fiscal Year - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 1 |
| Nov 2011 | N/A | 4 |
| Dec 2011 | N/A | 2 |
| Jan 2012 | N/A | 0 |
| Feb 2012 | N/A | 2 |
| Mar 2012 | N/A | 2 |
| Apr 2012 | N/A | 5 |
| May 2012 | N/A | 5 |
| Jun 2012 | N/A | 3 |
| Jul 2012 | N/A | 2 |
| Aug 2012 | N/A | 2 |
| Sep 2012 | N/A | 5 |
FY 2012 Total: 33
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.
