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U.S. Department of Health and Human Services

About FDA

18 Month, Ten Thousand Patient Reviews

Description: Rollout of Reviews

Accomplishment: These reviews are mandated under FDAAA (505(r)(2)(D)). 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, including identification of any new risks not previously identified, potential new risks, or known risks reported in unusual number is conducted. Through this project, OSE identified reviews to be completed, completed the reviews, and posted them on the FDA's Postmarketing Drug Safety Evaluations website14. Summaries of FDA safety analyses on recently approved products will now be periodically prepared and posted on FDA’s website along with a brief discussion of the steps FDA is taking to address any identified safety issues. OSE also issued a press release 15about this new effort to inform the public about the publication of these safety evaluations.

18 Month, Ten Thousand Patient Reviews

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Identify reviews to be completed

4/10/2010

Completed 4/10/2010

2. Complete background packages for reviews; signd off and archive in the Document Archiving, Reporting and Regulatory Tracking System (DAARTS)

4/26/2010

Completed 4/26/2010

3. Write summary narrative for reviews

4/30/2010

Completed 4/30/2010

4. Obtain clearance for summary reviews

6/7/2010

Completed 6/7/2010

5. Provide completed summaries to CDER Web Team for posting

6/10/2010

Completed 6/10/2010

6. Press release

6/15/2010

Completed 6/15/2010

7. Post on Web

6/15/2010

Completed 6/15/2010

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

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.