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U.S. Department of Health and Human Services

About FDA

21st Century Review

Description: 21st Century Review Process: develop a process to increase the quality, efficiency, clarity, transparency, and consistency of the marketing application and efficacy supplement review process

Accomplishment: The 21st Century Review process was first established under a pilot program 2008 to make the marketing application (New Drug Applications (NDA) and Biologics License Applications (BLA)) review process more organized and integrated and was designed to allow sufficient time at the end of the process to be sure all concerns have been heard and addressed by the decision makers. The process was developed by the efforts of many CDER staff members to ensure that reviewers follow the principles and timelines described in FDA’s Guidance for Review Staff and Industry: Good Review Management Principles and Practices for PDUFA Products (2005). The process describes the distinct roles of review participants and signatory authorities and also includes numerous process improvements identified by CDER staff. The 21st Century Review was phased in beginning in FY 2009 (original BLAs and new molecular entity (NME) NDAs), followed by efficacy supplements for new or expanded indications in FY 2010, all BLAs and NDAs in FY 2011, and finally all efficacy supplements in FY 2012. As such, OND has now fully phased-in the implementation of this review process into the review of all marketing applications and efficacy supplements. The process has enabled review staff to engage in greater deliberation during the review phase, complete reviews earlier, and initiate earlier discussion of labeling and postmarketing requirements/commitments with industry, resulting in more consistent decision making as well as enhanced communications and transparency with industry.

Briefing Status: Completed

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Apply procedures to all marketing applications for innovative products that have never been approved


Completed 10/1/2008

2. Apply procedures to above applications plus efficacy supplements for new or expanded indications


Completed 10/1/2009

3. Apply procedures to above applications plus all original marketing applications


Completed 10/1/2010

4. Apply procedures to above applications plus all efficacy supplements


Completed 10/1/2011

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.


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.