01/16/2017
https://www.congress.gov...
"inherently suspect"
"The average cost, according to what I've been told, for a pharmaceutical drug is about a billion dollars..."
"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."