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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, 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 is included, including identification of any new risks not previously identified, potential new risks, or known risks reported in an unusual number

Information is current as of December 31, 2013.

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A1
Nov 2012N/A3
Dec 2012N/A1
Jan 2013N/A5
Feb 2013N/A1
Mar 2013N/A1
Apr 2013N/A1
May 2013N/A1
Jun 2013N/A2
Jul 2013N/A0
Aug 2013N/A0
Sep 2013N/A4

FY 2013 Total: 20

Footnotes

  • CDER created new measures and began collecting data in July 2012. Therefore, FY12 will only include 3 months of data.

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

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A1
Nov 2012N/A0
Dec 2012N/A2
Jan 2013N/A8
Feb 2013N/A1
Mar 2013N/A4
Apr 2013N/A2
May 2013N/A2
Jun 2013N/A0
Jul 2013N/A2
Aug 2013N/A5
Sep 2013N/A6

FY 2013 Total: 33

Footnotes

  • CDER created new measures and began collecting data in July 2012. Therefore, FY12 will only include 3 months of data.

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.