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FDA-TRACK Home Page or Center for Biologics Evaluation and Research Index

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 September 30, 2021

Fiscal Year - 2021

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TimeTargetNumber
Oct - Dec 2020N/A36
Jan - Mar 2021N/A34
Apr - Jun 2021N/A27
Jul - Sept 2021N/A34

FY 2021 Total: 131

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

Fiscal Year - 2021
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TimeTargetNumber
Oct - Dec 2020N/A1
Jan - Mar 2021N/A0
Apr - Jun 2021N/A0
Jul - Sept 2021N/A1

FY 2021 Total: 2

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.
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