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U.S. Department of Health and Human Services

About FDA

Number of Risk Evaluation Mitigation Strategy (REMS) approved

Dictionary: A Risk Evaluation and Mitigation Strategy (REMS) is a required risk management plan that uses tools, as specified in FDAAA, beyond routine professional labeling (the package insert) necessary to ensure that the benefits of a drug outweigh its risks. A REMS is an enforceable document included with the REMS approval letter that describes the elements that an applicant is required to implement.

Information is current as of March 31, 2014.

Fiscal Year - 2012

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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/A3
Aug 2012N/A0
Sep 2012N/A1

FY 2012 3 month Total: 4

Footnotes

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

Number of REMS assessment submitted

Fiscal Year - 2012

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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/A5

FY 2012 3 month Total: 10

Number of REMS modifications approved

Fiscal Year - 2012

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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/A7
Aug 2012N/A9
Sep 2012N/A5

FY 2012 3 month Total: 21

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.