Follow-On Biologics Will Rely On “Case-By-Case” Approach – Rep. Waxman
Executive Summary
FDA's development of a guidance for follow-on versions of insulin and human growth hormone will be a key milestone in demonstrating the agency's ability to implement a "case-by-case" approach to "generic" biologics, Rep. Henry Waxman (D-Calif.) said
You may also be interested in...
FDA Follow-On Biologics Public Meeting Slated For Early ’05
FDA and the Drug Information Association are looking at dates in early 2005 for a public meeting on scientific issues surrounding the development of follow-on biologics
FDA Follow-On Biologics Public Meeting Slated For Early ’05
FDA and the Drug Information Association are looking at dates in early 2005 for a public meeting on scientific issues surrounding the development of follow-on biologics
Follow-On Growth Hormone Has Precedent, Sandoz Says In Response To Pfizer
FDA's approval of Novo Nordisk's GlucaGen demonstrates that the agency has the legal authority to approve a follow-on version of human growth hormone, Sandoz maintains