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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 Application supplements (sNDAs) completed by ONDQA during the month (1)

Dictionary: Supplements to NDAs are applications to make changes to an approved marketing application. One of the types of changes made to approved NDAs are how or where the drug is manufactured and/or controlled. This measure includes all review associated the review of chemistry, manufacturing, and controls information submitted in NDA supplements.


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 - 2011

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TimeTargetNumber
Oct 2010N/A152
Nov 2010N/A154
Dec 2010N/A197
Jan 2011N/A192
Feb 2011N/A153
Mar 2011N/A156
Apr 2011N/A169
May 2011N/A152
Jun 2011N/A176
Jul 2011N/A125
Aug 2011N/A139
Sep 2011N/A168

FY 2011 Total: 1,933

Footnotes

  • (1) Includes all 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.