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U.S. Department of Health and Human Services

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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 - 2011

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TimeTargetPercent
Oct 201090100
Nov 201090100
Dec 201090100
Jan 201190100
Feb 201190100
Mar 201190100
Apr 201190100
May 201190100
Jun 201190100
Jul 201190100
Aug 201190100
Sep 201190100

FY 2011 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 - 2011
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TimeTargetNumber
Oct 2010N/A6
Nov 2010N/A3
Dec 2010N/A4
Jan 2011N/A6
Feb 2011N/A4
Mar 2011N/A11
Apr 2011N/A1
May 2011N/A4
Jun 2011N/A3
Jul 2011N/A3
Aug 2011N/A3
Sep 2011N/A1

FY 2011 Total: 49

Number of written responses to meeting requests due during the month that were provided within the specified PDUFA timeframes

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A6
Nov 2010N/A3
Dec 2010N/A4
Jan 2011N/A6
Feb 2011N/A4
Mar 2011N/A11
Apr 2011N/A1
May 2011N/A4
Jun 2011N/A3
Jul 2011N/A3
Aug 2011N/A3
Sep 2011N/A1

FY 2011 Total: 49

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.