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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 - 2012

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TimeTargetNumber
Oct 2011N/A171
Nov 2011N/A161
Dec 2011N/A121
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: 453

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.