FDA Drug Safety Website Could Cause More Harm Than Good, Novartis Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Novartis says risk information should be communicated quickly, but that it should be validated first, to avoid confusion. Company's comments come on heels of FDA's statement that Novartis' Elidel should have a black box, a move the company describes as unsubstantiated by clinical evidence and experience.