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U.S. Department of Health and Human Services

About FDA

Number of meeting summaries issued in the quarter

Dictionary: Each year, FDA review staffs participate in meetings with sponsors and applicants who seek guidance relating to the development and review of investigational new drugs and biologics, and drug or biological product marketing applications. These measures focus on the timeliness of providing written responses to pre-meeting questions that are submitted by sponsors before a scheduled face-to-face meeting. The Center’s goal is to provide comprehensive responses prior to the meeting to further advance the exchange of information leading to more efficient product development.

Information is current as of January 31, 2014

Fiscal Year - 2013

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TimeTargetNumber
October – December 2012N/A69
January – March 2013N/A58
April – June 2013N/A70
July – September 2013N/A60

FY 2013 Total: 257

Number of meeting summaries issued in the quarter that were past goal dates

Fiscal Year - 2013
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TimeTargetNumber
October – December 2012N/A3
January – March 2013N/A2
April – June 2013N/A4
July – September 2013N/A6

FY 2013 Total: 15

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.