Biologic Monographs Could Hinder Follow-On Products – USP CEO Williams
Executive Summary
Published monographs for biologics could hinder the development of follow-on products, United States Pharmacopeia CEO Roger Williams, MD, said
You may also be interested in...
USP Will Release Information Chapters On Follow-On Biologics Starting In ’05
United States Pharmacopoeia will publish information chapters on determining equivalence between follow-on and source biologics starting in 2005
USP Will Release Information Chapters On Follow-On Biologics Starting In ’05
United States Pharmacopoeia will publish information chapters on determining equivalence between follow-on and source biologics starting in 2005
Generic Biologic Science Must Evolve Before Legislative Debate – Lumpkin
FDA and industry need to work out the science of generic biologics before a legislative debate would be useful, FDA Principle Associate Commissioner Murray Lumpkin, MD, suggested