FDA Follow-On Biologics Public Meeting Slated For Early ’05
Executive Summary
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
You may also be interested in...
Follow-On Pathway Necessary For Industry To Be Invested, Woodcock Says
"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.
Follow-On Pathway Necessary For Industry To Be Invested, Woodcock Says
"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.
Follow-On Proteins Draft Guidance Will Be Followed By Third Public Meeting
FDA will hold a third public forum on follow-on proteins shortly after the release of a draft guidance on the topic, Acting Deputy Commissioner of Operations Janet Woodcock said Feb. 14