We expect data presented to us to come from an experimental design that's sound, because our own scientific experts are reviewing that data against.... We essentially go through the same process that would go into looking at information presented for a publication. As Karen mentioned in her remarks, in our review, we don't just say, “well, here's what the company's given us”; we're also looking at the wider scientific literature. Assessing their design and their outcomes against a backdrop of the entire scientific environment is an important consideration, and that doesn't just stop when an approval is granted. If anything emerges from the scientific literature, or if there's a new finding that is relevant, we'll go back and reassess if necessary.
On September 29th, 2016. See this statement in context.