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U.S. Department of Health and Human Services

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Number of 18 month, ten thousand patient reviews initiated in the month, New Molecular Entity (NME)

Dictionary: Once a drug has been approved for 18-months or has been used by 10,000 patients, whichever is later, a summary analysis of the adverse drug reaction reports received for the drug, including identification of any new risks not previously identified, potential new risks, or known risks reported in unusual number.


These measures 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/A0
Nov 2010N/A1
Dec 2010N/A0
Jan 2011N/A2
Feb 2011N/A2
Mar 2011N/A3
Apr 2011N/A2
May 2011N/A0
Jun 2011N/A0
Jul 2011N/A0
Aug 2011N/A0
Sep 2011N/A0

FY 2011 Total: 10

Number of 18 month, ten thousand patient reviews initiated in the month, non-NME

Dictionary: Once a drug has been approved for 18-months or has been used by 10,000 patients, whichever is later, a summary analysis of the adverse drug reaction reports received for the drug, including identification of any new risks not previously identified, potential new risks, or known risks reported in unusual number.

Fiscal Year - 2011

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TimeTargetNumber
Oct 2010N/A2
Nov 2010N/A0
Dec 2010N/A0
Jan 2011N/A4
Feb 2011N/A3
Mar 2011N/A2
Apr 2011N/A3
May 2011N/A1
Jun 2011N/A2
Jul 2011N/A0
Aug 2011N/A0
Sep 2011N/A0

FY 2011 Total: 17

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.