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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 - 2011

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Oct 2010N/AN/A
Nov 2010N/AN/A
Dec 2010N/AN/A
Jan 2011N/AN/A
Feb 2011N/A2
Mar 2011N/A2
Apr 2011N/A6
May 2011N/A2
Jun 2011N/A3
Jul 2011N/A3
Aug 2011N/A1
Sep 2011N/A0

FY 2011 Total: 19


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.