On Michael Taylor's report
Friday, November 17, 2006
Movanet
A few weeks ago I provide you with a link and analysis to Michael Taylor's paper criticizing FDA's institutional capability in supervising nano product. Recently, David Berube discuss this paper in his blog.
He considered these to be the primary question in Michael's paper. (1) 1. Should the FDA be given more responsibilities or is it time to break it into smaller entities to consider different issues? and (2) Should all nano-formulations (drugs) and sometimes drug/devices be treated as new for purposes of regulation? and (3) Should the burden to demonstrate safety be precautionary (in a strict sense)?
He provided the answers in his blog.
He considered these to be the primary question in Michael's paper. (1) 1. Should the FDA be given more responsibilities or is it time to break it into smaller entities to consider different issues? and (2) Should all nano-formulations (drugs) and sometimes drug/devices be treated as new for purposes of regulation? and (3) Should the burden to demonstrate safety be precautionary (in a strict sense)?
He provided the answers in his blog.