• Decrease
  • Normal
  • Increase
U.S. Department of Health and Human Services

About FDA

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 June 30, 2014.

Fiscal Year - 2012

Skip graphic and jump to text data

TimeTargetNumber
Oct 2011N/AN/A
Nov 2011N/AN/A
Dec 2011N/AN/A
Jan 2012N/AN/A
Feb 2012N/AN/A
Mar 2012N/AN/A
Apr 2012N/AN/A
May 2012N/AN/A
Jun 2012N/AN/A
Jul 2012N/A2
Aug 2012N/A3
Sep 2012N/A1

FY 2012 3 month Total: 6

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 - 2012

Skip graphic and jump to text data

TimeTargetNumber
Oct 2011N/AN/A
Nov 2011N/AN/A
Dec 2011N/AN/A
Jan 2012N/AN/A
Feb 2012N/AN/A
Mar 2012N/AN/A
Apr 2012N/AN/A
May 2012N/AN/A
Jun 2012N/AN/A
Jul 2012N/A6
Aug 2012N/A1
Sep 2012N/A2

FY 2012 3 month Total: 9

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.