About FDA
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
| Time | Target | Number |
|---|---|---|
| Oct 2009 | N/A | 53 |
| Nov 2009 | N/A | 43 |
| Dec 2009 | N/A | 44 |
| Jan 2010 | N/A | 44 |
| Feb 2010 | N/A | 43 |
| Mar 2010 | N/A | 55 |
| Apr 2010 | N/A | 48 |
| May 2010 | N/A | 44 |
| Jun 2010 | N/A | 60 |
| Jul 2010 | N/A | 46 |
| Aug 2010 | N/A | 40 |
| Sep 2010 | N/A | 50 |
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.
