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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 - 2015

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TimeTargetNumber
October – December 2014N/A71
January – March 2015N/A50
April – June 2015N/ATBD
July – September 2015N/ATBD

FY 2015 YTD: 121

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

Fiscal Year - 2015
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TimeTargetNumber
October – December 2014N/A0
January – March 2015N/A2
April – June 2015N/ATBD
July – September 2015N/ATBD

FY 2015 YTD: 2

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.