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Critical Path follow-on biologics projects idle

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Executive Summary

FDA Chief Medical Officer Janet Woodcock says there is little interest by industry in follow-on biologics projects under the Critical Path Initiative. "I don't think that we've gotten a lot of partners to work on those different projects, they are not very prominent," she observes. The agency's opportunities list includes two projects - Novel Approaches to Characterizing and Standardizing Biological Products and Enabling Manufacturing Changes for Well-Characterized Proteins - that could clarify underlying scientific issues complicating development of regulatory policy on follow-on biologics (1"The Pink Sheet" April 10, 2006, p. 13)...

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