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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 - 2012

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Oct 2011N/A2
Nov 2011N/A2
Dec 2011N/A5
Jan 2012N/A3
Feb 2012N/A1
Mar 2012N/A5
Apr 2012N/A2
May 2012N/A3
Jun 2012N/A1
Jul 2012N/A0
Aug 2012N/A5
Sep 2012N/A2

FY 2012 Total: 31


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.