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Percentage of times a written response to a meeting request (including date, time and place for the meeting, as well as expected Center participants) is provided within the Prescription Drug User Fee Act (PDUFA) timeframes (1)
Dictionary: The purpose of formal meetings with sponsors is to provide guidance on product development and submission of investigational and marketing applications. Requests must contain specific information, or they will not be processed. FDA’s Guidance for Industry on “Formal Meetings with Sponsors and Applicants for PDUFA Products” outlines the requirements for meeting requests. This measure will provide OCTGT performance data on the percentage of responses to meeting requests provided within established timeframes.
Information is current as of September 30, 2012
Fiscal Year - 2010
| Time | Target | Percent |
|---|---|---|
| Oct 2009 | 90 | 100 |
| Nov 2009 | 90 | 100 |
| Dec 2009 | 90 | 100 |
| Jan 2010 | 90 | 100 |
| Feb 2010 | 90 | 100 |
| Mar 2010 | 90 | 100 |
| 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 Overall: 100%
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 written responses to meeting requests due during the month
Fiscal Year - 2010
| Time | Target | Number |
|---|---|---|
| Oct 2009 | N/A | 5 |
| Nov 2009 | N/A | 3 |
| Dec 2009 | N/A | 2 |
| Jan 2010 | N/A | 5 |
| Feb 2010 | N/A | 3 |
| Mar 2010 | N/A | 3 |
| Apr 2010 | N/A | 8 |
| May 2010 | N/A | 6 |
| Jun 2010 | N/A | 2 |
| Jul 2010 | N/A | 4 |
| Aug 2010 | N/A | 7 |
| Sep 2010 | N/A | 7 |
FY 2010 Total: 55
Number of written responses to meeting requests due during the month that were provided within the specified PDUFA timeframes
Fiscal Year - 2010
| Time | Target | Number |
|---|---|---|
| Oct 2009 | N/A | 5 |
| Nov 2009 | N/A | 3 |
| Dec 2009 | N/A | 2 |
| Jan 2010 | N/A | 5 |
| Feb 2010 | N/A | 3 |
| Mar 2010 | N/A | 3 |
| Apr 2010 | N/A | 8 |
| May 2010 | N/A | 6 |
| Jun 2010 | N/A | 2 |
| Jul 2010 | N/A | 4 |
| Aug 2010 | N/A | 7 |
| Sep 2010 | N/A | 7 |
FY 2010 Total: 55
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.
