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U.S. Department of Health and Human Services

About FDA

Total number of new labels (postmarketing) approved in the fiscal year that include clinical pharmacology review on pharmacogenetic, drug-drug interactions and specific population information, etc.

Measure was implemented starting January 2011

Dictionary: These labeling update are considered important to enhance the safe and effective use of drug products even after they are approved. Most times they are based on new knowledge and fulfillment of post-marketing requirement or commitment.


These measures have been retired as CDER has created new measures for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research.

Fiscal Year - 2011

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Measure was implemented starting January 2011

TimeTargetNumber
Jan 2011N/A13
Feb 2011N/A23
Mar 2011N/A14
Apr 2011N/A14
May 2011N/A14
Jun 2011N/A27
Jul 2011N/A14
Aug 2011N/A12
Sep 2011N/A13

Cumulative number of new labels (postmarketing) approved

Measure was implemented starting January 2011

Dictionary: These labeling update are considered important to enhance the safe and effective use of drug products even after they are approved. Most times they are based on new knowledge and fulfillment of post-marketing requirement or commitment.

Fiscal Year - 2011

Skip graphic and jump to text data

Measure was implemented starting January 2011

TimeTargetNumber
Jan 2011N/A13
Feb 2011N/A36
Mar 2011N/A50
Apr 2011N/A64
May 2011N/A78
Jun 2011N/A105
Jul 2011N/A119
Aug 2011N/A131
Sep 2011N/A144

Glossary

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.