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U.S. Department of Health and Human Services

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Number of internal and external safety and product assessment meetings in the month

Dictionary: Each month an assessment of how many products will be eligible for a pediatric focused safety review is identified. The products are then assessed for timing for presentation to the Pediatric Advisory Committee, based on labeling date and extent of possible discussion or other class product issues. A series of meetings involving postmarket surveillance and drug utilization staff, the technical division, pediatricians and others are coordinated by OPT to evaluate the known issues, establish responsibilities, timelines and future meetings to further define issues and the advisory committee agenda.

Information is current as of March 31, 2020.

Fiscal Year - 2020

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TimeTargetNumber of Meetings
Oct 2019N/A3
Nov 2019N/A2
Dec 2019N/A2
Jan 2020N/A13
Feb 2020N/A6
Mar 2020N/A9
Apr 2020N/ATBD
May 2020N/ATBD
Jun 2020N/ATBD
Jul 2020N/ATBD
Aug 2020N/ATBD
Sep 2020N/ATBD

FY 2020 YTD: 35

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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