United States Food and Drug Administration Advisory Committee outcomes and agency approval analysis from 2010 to 2015

The results support past research examining the topic from 2001 to 2010. Voting patterns were relatively constant, and they generally heavily favored one outcome. The FDA's ultimate approval decision was in line with the AC vote the vast majority of cases. Any disagreement was usually due to FDA having a differing opinion regarding clinical importance, furthering the notion that AC insight is heavily considered but not the final determinant in agency action. This topic has importance in understanding pharmaceutical approval in the United States, and this has clinical practice implications.