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U.S. Department of Health and Human Services

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Number of meetings held in the quarter (including meetings conducted in a Written Response format)

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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Oct - Dec 2020N/A30
Jan - Mar 2021N/A31
Apr - Jun 2021N/A119
Jul - Sept 2021N/A141

FY 2021 Total: 321

Number of meetings cancelled by the requestor in the quarter because written feedback was provided prior to the scheduled meeting

Fiscal Year - 2021

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Oct - Dec 2020N/A8
Jan - Mar 2021N/A6
Apr - Jun 2021N/A7
Jul - Sept 2021N/A4

FY 2021 Total: 25

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.