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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 - 2012

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TimeTargetPercent
Oct 201190100
Nov 201190100
Dec 201190N/A
Jan 201290100
Feb 201290100
Mar 201290100
Apr 201290100
May 201290100
Jun 201290100
Jul 201290100
Aug 201290100
Sep 201290100

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
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TimeTargetNumber
Oct 2011N/A2
Nov 2011N/A3
Dec 2011N/A0
Jan 2012N/A5
Feb 2012N/A5
Mar 2012N/A8
Apr 2012N/A4
May 2012N/A4
Jun 2012N/A5
Jul 2012N/A6
Aug 2012N/A5
Sep 2012N/A4

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
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TimeTargetNumber
Oct 2011N/A2
Nov 2011N/A3
Dec 2011N/A0
Jan 2012N/A5
Feb 2012N/A5
Mar 2012N/A8
Apr 2012N/A4
May 2012N/A4
Jun 2012N/A5
Jul 2012N/A6
Aug 2012N/A5
Sep 2012N/A4

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.