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U.S. Department of Health and Human Services

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Number of medical products studied in children with pediatric safety labeling changes in the month

Dictionary: The number of Food and Drug Administration Amendments Act (FDAAA) pediatric labeling changes per month that must have safety reporting to the Pediatric Advisory Committee (PAC). (This is not the number of products but rather the number of labeling changes. A product can have more than one labeling change. If so, it is counted as two labeling changes.)

Information is current as of December 31, 2014.

Fiscal Year - 2015

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Oct 2014N/A5
Nov 2014N/A3
Dec 2014N/A6
Jan 2015N/ATBD
Feb 2015N/ATBD
Mar 2015N/ATBD
Apr 2015N/ATBD
May 2015N/ATBD
Jun 2015N/ATBD
Jul 2015N/ATBD
Aug 2015N/ATBD
Sep 2015N/ATBD

FY 2015 YTD: 14


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.