FDA Is Listening: Adolor Cited For Downplaying REMS At Conference
A company representative's oral statement that the REMS for the gastrointestinal surgery recovery drug Entereg is "due to logistics" was unacceptable, DDMAC letter says.
A company representative's oral statement that the REMS for the gastrointestinal surgery recovery drug Entereg is "due to logistics" was unacceptable, DDMAC letter says.