Prasugrel REMS: Lilly Proposes MedGuide, FDA Wants More To Mitigate Risks
Lilly’s proposed REMS consists only of a Medication Guide warning of bleeding risk; FDA suggests the addition of a communication plan regarding the possible cancer risk.
Lilly’s proposed REMS consists only of a Medication Guide warning of bleeding risk; FDA suggests the addition of a communication plan regarding the possible cancer risk.