www.fdanews.com/articles/179991-cber-hits-performance-goals
CBER Hits Performance Goals
January 12, 2017
The Center for Biologics Research and Evaluation said it met its performance goals for reviewing and acting on applications and supplements for biologics.
In a report, CBER Director Peter Marks said 100 percent of standard and priority BLAs were reviewed on time.
Last year, CBER published 12 guidance documents — four of which were released in cooperation with CDER or CDRH.