Switch Case Study: GSK Alli Review Shows FDA Data Mining In Context
This article was originally published in The Tan Sheet
Executive Summary
[F-D-C Reports' Pharmaceutical Approvals Monthly dissects drug reviews by FDA. While each drug stands or fails alone, a specific review can provide valuable insight into FDA's interpretation of data, policy and guidance documents, recurring controversies and resolution of internal disagreement. This story completes a two-part feature on alli.