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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 June 30, 2019.

Fiscal Year - 2019

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TimeTargetNumber of Meetings
Oct 2018N/A24
Nov 2018N/A4
Dec 2018N/A12
Jan 2019N/A6
Feb 2019N/A8
Mar 2019N/A10
Apr 2019N/A5
May 2019N/A9
Jun 2019N/A9
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

FY 2019 YTD: 87

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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