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U.S. Department of Health and Human Services

About FDA

Prescription Drug User Fee Act (PDUFA) Reauthorization

Description: Activities to support reauthorization of the Prescription Drug User Fee Act (PDUFA) to ensure sound financial support for new drug review.

Prescription Drug User Fee Act (PDUFA) Reauthorization

Briefing Status: COMPLETED

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Gather feedback on suggestions regarding reauthorization including specific suggestions for changes to the PDUFA goals, hold a public meeting and open a docket to gather written comments

5/1/2010

Completed 5/1/2010

2. Analyze written comments submitted to the docket to inform stakeholder and industry discussions

6/30/2010

Completed 6/30/2010

3. Meet monthly (starting in June) with representatives of patient and consumer advocacy groups to continue discussions to inform FDA on recommendations for reauthorization

5/31/2011

Completed 5/31/2011

4. Conduct negotiations and reach agreement with the regulated industry on user fee program reauthorization

5/31/2011

Completed 5/31/2011

5. Submit package of proposal recommendations for reauthorization for administration review and clearance

6/1/2011

Completed 6/1/2011

6. To gather feedback on the proposal recommendations for reauthorization , hold a public meeting, and open a docket to gather written comments

11/15/2011

Completed 11/15/2011

7. Analyze written comments submitted to the docket

12/15/2011

Completed 12/15/2011

8. Transmit final package of prepared recommendations for reauthorization to Congress by January 15, 2012

1/15/2012

Completed 1/15/2012

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.