• Decrease
  • Normal
  • Increase
U.S. Department of Health and Human Services

About FDA

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 - 2010

Skip graphic and jump to text data

TimeTargetPercent
Oct 20099088
Nov 200990100
Dec 200990100
Jan 201090100
Feb 201090100
Mar 201090100
Apr 201090100
May 201090100
Jun 201090100
Jul 20109080
Aug 201090100
Sep 201090-

FY 2010 Overall: 95%

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 - 2010
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2009N/A7
Nov 2009N/A4
Dec 2009N/A6
Jan 2010N/A3
Feb 2010N/A1
Mar 2010N/A2
Apr 2010N/A6
May 2010N/A4
Jun 2010N/A2
Jul 2010N/A4
Aug 2010N/A1
Sep 2010N/A0

FY 2010 Total: 40

Number of meeting minutes due during the month

Fiscal Year - 2010
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2009N/A8
Nov 2009N/A4
Dec 2009N/A6
Jan 2010N/A3
Feb 2010N/A1
Mar 2010N/A2
Apr 2010N/A6
May 2010N/A4
Jun 2010N/A2
Jul 2010N/A5
Aug 2010N/A1
Sep 2010N/A0

FY 2010 Total: 42

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.