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U.S. Department of Health and Human Services

About FDA

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

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TimeTargetPercent
Oct 200990100
Nov 200990100
Dec 200990100
Jan 201090100
Feb 201090100
Mar 201090100
Apr 201090100
May 201090100
Jun 201090100
Jul 201090100
Aug 201090100
Sep 201090100

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
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TimeTargetNumber
Oct 2009N/A5
Nov 2009N/A3
Dec 2009N/A2
Jan 2010N/A5
Feb 2010N/A3
Mar 2010N/A3
Apr 2010N/A8
May 2010N/A6
Jun 2010N/A2
Jul 2010N/A4
Aug 2010N/A7
Sep 2010N/A7

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
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TimeTargetNumber
Oct 2009N/A5
Nov 2009N/A3
Dec 2009N/A2
Jan 2010N/A5
Feb 2010N/A3
Mar 2010N/A3
Apr 2010N/A8
May 2010N/A6
Jun 2010N/A2
Jul 2010N/A4
Aug 2010N/A7
Sep 2010N/A7

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.