MUST READ! Jonathan E. Levitt, Esq. and Jesse C. Dresser, Esq., Take on the DSQA

read here  They restate or reword a lot of what the FDA website or guidance says, but it is interesting, but not unexpected, to see the claim that the FDA is ususurping authority not defined by the statute. This may be an indication of fights yet to come in court over this statute, FDA's authority, and ulimately a second look by Congress whether it was clear enough or not on the subject.