5 January 2017 - This letter is the Director's first annual report to various stakeholders. It summarises what Center have done over the past year, and includes regulatory, research, and administrative accomplishments that demonstrate the extraordinary work of our staff. 

You will also notice in this letter that, following the CBER restructuring, which occurred in FY 2017, the Office of Cellular, Tissue and Gene Therapies became the Office of Tissues and Advanced Therapies. Therefore, we will use that terminology in this report.

In fiscal year 2016, I am pleased to report that CBER enhanced its operational efficiency, which facilitated getting new treatments to the public. For example, as of 30 September 2016, the Center exceeded its regulatory performance target by completing 100% of standard and priority reviews of biologics license applications and new drug applications within specified review timeframes. Similarly, CBER exceeded the performance target for 510(k) submissions and real time supplements, issuing a decision on 100% of Medical Device User Fee amendments submissions received during FY 2016 within 90 FDA days.

Read CBER Director's report