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U.S. Department of Health and Human Services

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Number of written Chemistry, Manufacturing, and Controls (CMC) reviews for New Drug Applications (NDAs) completed by ONDQA during the month (1)

Dictionary: New Drug Applications (NDA) are applications to request permission to market a drug product in the U.S. for a specific use. ONDQA reviews the Chemistry, manufacturing, and controls information submitted in the NDA to ensure product quality (i.e., identity, strength, quality, purity, and potency) as it relates to the safety and efficacy of the drug product. This measure includes all review associated the review of chemistry, manufacturing, and controls information submitted in NDAs prior to approval.


This measure has 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 - 2010

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TimeTargetNumber
Oct 2009N/A53
Nov 2009N/A43
Dec 2009N/A44
Jan 2010N/A44
Feb 2010N/A43
Mar 2010N/A55
Apr 2010N/A48
May 2010N/A44
Jun 2010N/A60
Jul 2010N/A46
Aug 2010N/A40
Sep 2010N/A50

FY 2010 Total: 570

Footnotes

  • (1) Includes all initial quality assessment (IQA) reviews, primary reviews, summary and executive reviews.

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.