11/16/2015
https://www.congress.gov...
"We believe these findings will say quite a bit about the lack of accountability for these types of business relationships or arrangements."
"Simply put, PODs are medical device businesses in which a physician is both an investor and a distributor--essentially a salesperson--of either the devices or some of the components."
"FDA's proposal to regulate LDTs is a significant change that would impose considerable new burdens on regulated parties."
"If we don't allow enough data exclusivity time, we're not going to develop these therapies, especially in bio, because bio is one of four or five places, four or five techniques, where we can actually..."