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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 - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 0 |
| Nov 2011 | N/A | 4 |
| Dec 2011 | N/A | 1 |
| Jan 2012 | N/A | TBD |
| Feb 2012 | N/A | TBD |
| Mar 2012 | N/A | TBD |
| Apr 2012 | N/A | TBD |
| May 2012 | N/A | TBD |
| Jun 2012 | N/A | TBD |
| Jul 2012 | N/A | TBD |
| Aug 2012 | N/A | TBD |
| Sep 2012 | N/A | TBD |
FY 2012 YTD: 5
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 - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 5 |
| Nov 2011 | N/A | 2 |
| Dec 2011 | N/A | 6 |
| Jan 2012 | N/A | TBD |
| Feb 2012 | N/A | TBD |
| Mar 2012 | N/A | TBD |
| Apr 2012 | N/A | TBD |
| May 2012 | N/A | TBD |
| Jun 2012 | N/A | TBD |
| Jul 2012 | N/A | TBD |
| Aug 2012 | N/A | TBD |
| Sep 2012 | N/A | TBD |
FY 2012 YTD: 13
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 - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 1 |
| Nov 2011 | N/A | 0 |
| Dec 2011 | N/A | 3 |
| Jan 2012 | N/A | TBD |
| Feb 2012 | N/A | TBD |
| Mar 2012 | N/A | TBD |
| Apr 2012 | N/A | TBD |
| May 2012 | N/A | TBD |
| Jun 2012 | N/A | TBD |
| Jul 2012 | N/A | TBD |
| Aug 2012 | N/A | TBD |
| Sep 2012 | N/A | TBD |
FY 2012 YTD: 4
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.
