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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 June 30, 2014.

Fiscal Year - 2013

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

FY 2013 Total: 10

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 - 2013

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TimeTargetNumber
Oct 2012N/A6
Nov 2012N/A1
Dec 2012N/A1
Jan 2013N/A7
Feb 2013N/A4
Mar 2013N/A4
Apr 2013N/A3
May 2013N/A5
Jun 2013N/A3
Jul 2013N/A5
Aug 2013N/A11
Sep 2013N/A3

FY 2013 Total: 53

Number of REMS modifications approved

Fiscal Year - 2013

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

FY 2013 Total: 27

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.