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FDA Sees Critical Path Opportunity To Address Follow-On Biologics

Executive Summary

FDA's Critical Path opportunities list suggests that the agency is actively working to lay the scientific groundwork for follow-on biologics

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FDA Gets Practical On Follow-On Biologics As Pathway Remains Theoretical

Although a pathway for follow-on biologics has not been established by Congress, FDA is offering industry a description of what some of the paving stones could look like

FDA Gets Practical On Follow-On Biologics As Pathway Remains Theoretical

Although a pathway for follow-on biologics has not been established by Congress, FDA is offering industry a description of what some of the paving stones could look like

Critical Path follow-on biologics projects idle

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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