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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 - 2013

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Oct 2012N/A4
Nov 2012N/A2
Dec 2012N/A2
Jan 2013N/A1
Feb 2013N/A3
Mar 2013N/A6
Apr 2013N/A4
May 2013N/A3
Jun 2013N/A3
Jul 2013N/A1
Aug 2013N/A6
Sep 2013N/A0

FY 2013 Total: 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.