why does Promacta have a REMS in the first place? I thought a REMS was reserved for drugs with side effect issues or at least a somewhat questionable risk/benefit profile. What are the specifics as it relates to Promacta?
That was the original conception for REMS programs, but it has become an out-of-control bureaucratic monster.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”