Follow-On Pathway Necessary For Industry To Be Invested, Woodcock Says
Executive Summary
"The Pink Sheet" sat down with FDA Chief Medical Officer Janet Woodcock to discuss the agency's forthcoming guidances related to follow-on proteins. Woodcock testified that the agency is in the process of developing guidance for approval of follow-on biologics under the 505(b)(2) pathway at the House Oversight and Government Reform Committee hearing on generic biologics March 26 (1"The Pink Sheet" April 2, 2007, p. 13). Woodcock has been a long-time champion of the scientific issues that underscore the follow-on debate, including the need for the terminology of "follow-on proteins" to be clear that the products are biotech proteins.