ParagonRx® | Minimize Risk and Optimize Use

Add three more drugs whose commercial availability is contingent on a risk evaluation and mitigation strategy: Aranesp, Epogen and Procrit. All three are erythropoiesis-stimulating agents (ESAs) made by Amgen and Centocor Ortho Biotech Products. We reported earlier this week that Auxilium's just-approved biologic for a progressive hand disease also requires one.

Consultancy BioTrak Market Intelligence has launched REMSadvisor.com, a resource for those developing risk evaluation and mitigation strategies. REMS have become an increasingly required approval component for drugs that the FDA deems to have safety risks.