21st Century Review Process: develop a process to increase the quality, efficiency, clarity, transparency, and consistency of the marketing application and efficacy supplement review processThe 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.CompletedON TRACK1. Apply procedures to all marketing applications for innovative products that have never been approved10/1/2008Completed10/1/20082. Apply procedures to above applications plus efficacy supplements for new or expanded indications10/1/2009Completed10/1/20093. Apply procedures to above applications plus all original marketing applications10/1/2010Completed10/1/20104. Apply procedures to above applications plus all efficacy supplements10/1/2011Completed10/1/2011http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htmFDA-TRACK CDER Dashboard ਍††਍਍਍਍਍਍਍