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Percentage of written meeting responses that were sent greater than two FDA business days in advance of the meeting (1)
Dictionary: This measure focuses on the timeliness of providing written responses to pre-meeting questions that are submitted by sponsors before a scheduled face-to-face meeting. OBRR's goal is to provide comprehensive responses prior to the meeting to further advance the exchange of information leading to more efficient product development.
Information is current as of September 30, 2012
Fiscal Year - 2011
| Time | Target | Percent |
|---|---|---|
| Oct 2010 | 75 | 93 |
| Nov 2010 | 75 | 100 |
| Dec 2010 | 75 | 80 |
| Jan 2011 | 75 | 100 |
| Feb 2011 | 75 | 60 |
| Mar 2011 | 75 | 60 |
| Apr 2011 | 75 | 60 |
| May 2011 | 75 | 47 |
| Jun 2011 | 75 | 67 |
| Jul 2011 | 75 | 71 |
| Aug 2011 | 75 | 78 |
| Sep 2011 | 75 | 75 |
FY 2011 Overall: 73%
Footnotes
- (1) FDA business days are Monday through Friday.
Number of written meeting responses during the month that were faxed/emailed greater than two FDA business days in advance of the meeting
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 13 |
| Nov 2010 | N/A | 11 |
| Dec 2010 | N/A | 4 |
| Jan 2011 | N/A | 3 |
| Feb 2011 | N/A | 3 |
| Mar 2011 | N/A | 3 |
| Apr 2011 | N/A | 6 |
| May 2011 | N/A | 9 |
| Jun 2011 | N/A | 4 |
| Jul 2011 | N/A | 5 |
| Aug 2011 | N/A | 7 |
| Sep 2011 | N/A | 9 |
FY 2011 Total: 77
Number of written meeting responses during the month that were faxed/emailed two FDA business days or less in advance of the meeting
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 1 |
| Nov 2010 | N/A | 0 |
| Dec 2010 | N/A | 1 |
| Jan 2011 | N/A | 0 |
| Feb 2011 | N/A | 2 |
| Mar 2011 | N/A | 2 |
| Apr 2011 | N/A | 4 |
| May 2011 | N/A | 10 |
| Jun 2011 | N/A | 2 |
| Jul 2011 | N/A | 2 |
| Aug 2011 | N/A | 2 |
| Sep 2011 | N/A | 3 |
FY 2011 Total: 29
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.







