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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 - 2012
| Time | Target | Percent |
|---|---|---|
| Oct 2011 | 90 | 100 |
| Nov 2011 | 90 | 100 |
| Dec 2011 | 90 | N/A |
| Jan 2012 | 90 | 100 |
| Feb 2012 | 90 | 100 |
| Mar 2012 | 90 | 100 |
| 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: 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 - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 2 |
| Nov 2011 | N/A | 3 |
| Dec 2011 | N/A | 0 |
| Jan 2012 | N/A | 5 |
| Feb 2012 | N/A | 5 |
| Mar 2012 | N/A | 8 |
| Apr 2012 | N/A | 4 |
| May 2012 | N/A | 4 |
| Jun 2012 | N/A | 5 |
| Jul 2012 | N/A | 6 |
| Aug 2012 | N/A | 5 |
| Sep 2012 | N/A | 4 |
FY 2012 Total: 51
Number of written responses to meeting requests due during the month that were provided within the specified PDUFA timeframes
Fiscal Year - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 2 |
| Nov 2011 | N/A | 3 |
| Dec 2011 | N/A | 0 |
| Jan 2012 | N/A | 5 |
| Feb 2012 | N/A | 5 |
| Mar 2012 | N/A | 8 |
| Apr 2012 | N/A | 4 |
| May 2012 | N/A | 4 |
| Jun 2012 | N/A | 5 |
| Jul 2012 | N/A | 6 |
| Aug 2012 | N/A | 5 |
| Sep 2012 | N/A | 4 |
FY 2012 Total: 51
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.
