• Decrease
  • Normal
  • Increase
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.

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 - 2012

Skip graphic and jump to text data

TimeTargetNumber
Oct 2011N/A25
Nov 2011N/A14
Dec 2011N/A23
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 62

Cumulative number of new labels (postmarketing) approved

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 - 2012

Skip graphic and jump to text data

TimeTargetNumber
Oct 2011N/A25
Nov 2011N/A39
Dec 2011N/A62
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 206

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.