FDA Concerns About Baraclude Cancer Risk Tempered By Hepatitis B Virus Oncogenicity
This article was originally published in The Pink Sheet Daily
Executive Summary
After Carcinogenicity Assessment Committee establishes a potential risk in humans, Bristol proposes 12,500-patient, long-term, postmarketing safety study. Implications and design of the study are a primary focus of reviewers' discussion of hepatitis B agent's safety.