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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 March 31, 2015

Fiscal Year - 2014

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October – December 2013N/A66
January – March 2014N/A59
April – June 2014N/A61
July – September 2014N/A61

FY 2014 Total: 247

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

Fiscal Year - 2014
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October – December 2013N/A1
January – March 2014N/A1
April – June 2014N/A5
July – September 2014N/A3

FY 2014 Total: 10


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.