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.

• FY 2011
• FY 2012
• All

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.