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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 - 2012

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TimeTargetPercent
Oct 201190100
Nov 201190100
Dec 201190100
Jan 201290N/A
Feb 201290100
Mar 20129050
Apr 201290100
May 201290100
Jun 201290100
Jul 201290100
Aug 201290100
Sep 201290100

FY 2012 Overall: 97%

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 - 2012
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TimeTargetNumber
Oct 2011N/A1
Nov 2011N/A4
Dec 2011N/A2
Jan 2012N/A0
Feb 2012N/A2
Mar 2012N/A1
Apr 2012N/A5
May 2012N/A5
Jun 2012N/A3
Jul 2012N/A2
Aug 2012N/A2
Sep 2012N/A5

FY 2012 Total: 32

Number of meeting minutes due during the month

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A1
Nov 2011N/A4
Dec 2011N/A2
Jan 2012N/A0
Feb 2012N/A2
Mar 2012N/A2
Apr 2012N/A5
May 2012N/A5
Jun 2012N/A3
Jul 2012N/A2
Aug 2012N/A2
Sep 2012N/A5

FY 2012 Total: 33

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.