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U.S. Department of Health and Human Services

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Percentage of times that meeting minutes are sent within 30 days of the meeting date (Prescription Drug User Fee Act [PDUFA]) (1)

Dictionary: OCTGT will prepare minutes which will be available to the sponsor 30 calendar days after the meeting. The minutes will clearly outline, in bulleted form, important agreements, disagreements, issues for further discussion, and action items from the meeting. This measure focuses on the percentage of completed meeting minutes provided to sponsors 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 20119075
Aug 201190100
Sep 201190100

FY 2011 Overall: 98%

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 meeting minutes due during the month that were sent to sponsors within the specified PDUFA timeframes

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A5
Nov 2010N/A3
Dec 2010N/A4
Jan 2011N/A3
Feb 2011N/A4
Mar 2011N/A7
Apr 2011N/A2
May 2011N/A2
Jun 2011N/A5
Jul 2011N/A3
Aug 2011N/A4
Sep 2011N/A2

FY 2011 Total: 44

Number of meeting minutes due during the month

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A5
Nov 2010N/A3
Dec 2010N/A4
Jan 2011N/A3
Feb 2011N/A4
Mar 2011N/A7
Apr 2011N/A2
May 2011N/A2
Jun 2011N/A5
Jul 2011N/A4
Aug 2011N/A4
Sep 2011N/A2

FY 2011 Total: 45

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.