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505(b)(2) Resurrection, FDA Guidance To Bless Follow-On Biologics Pathway

Executive Summary

FDA's decision to develop guidance for development of follow-on versions of biologics approved under the Food, Drug & Cosmetic Act indicates the agency has accepted section 505(b)(2) of the FD&C Act as a viable pathway for approval of such products

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"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.

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