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

About FDA

Initial Risk Evaluation and Mitigation Strategy (REMS) reviews completed in the month

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.


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 - 2010

Skip graphic and jump to text data

TimeTargetNumber
Oct 2009N/A11
Nov 2009N/A6
Dec 2009N/A15
Jan 2010N/A10
Feb 2010N/A9
Mar 2010N/A2
Apr 2010N/A3
May 2010N/A3
Jun 2010N/A4
Jul 2010N/A6
Aug 2010N/A3
Sep 2010N/A5

Number of REMS assessments completed in the month

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.

Fiscal Year - 2010

Skip graphic and jump to text data

TimeTargetNumber
Oct 2009N/A0
Nov 2009N/A1
Dec 2009N/A1
Jan 2010N/A0
Feb 2010N/A1
Mar 2010N/A2
Apr 2010N/A3
May 2010N/A2
Jun 2010N/A4
Jul 2010N/A4
Aug 2010N/A2
Sep 2010N/A3

Number of REMS approved in the month

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.

Fiscal Year - 2010

Skip graphic and jump to text data

TimeTargetNumber
Oct 2009N/A6
Nov 2009N/A3
Dec 2009N/A1
Jan 2010N/A0
Feb 2010N/A2
Mar 2010N/A7
Apr 2010N/A3
May 2010N/A1
Jun 2010N/A8
Jul 2010N/A5
Aug 2010N/A4
Sep 2010N/A3

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.